Study Number: Title: Rationale: Phase: Study Period Study Design: Centres: Indication Treatment: Objectives: Primary Outcome/Efficacy Variable:
|
|
- Marvin Greene
- 5 years ago
- Views:
Transcription
1 The study listed may include approved and non-approved uses, formulations or treatment regimens. The results reported in any single study may not reflect the overall results obtained on studies of a product. Before prescribing any product mentioned in this Register, healthcare professionals should consult prescribing information for the product approved in their country. Study Number: (HPV-052 EXT ) Title: Gynaecological follow-up of a subset of / study subjects Rationale: The aim of this study was to follow-up of a subset of / study subjects who were either cervical cytology negative and oncogenic HPV positive or pregnant at their final / study visit (Visit 10 at Month 48) Phase: IIIb Study Period: From 05 Aug 2009 to 20 Jan 2014 Study Design: Open study on one group, multi-centre Centres: 85 centres: 5 in Australia, 3 in Belgium, 3 in Brazil, 5 in Canada, 15 in Finland, 14 in Germany, one in Italy, 7 in Philippines, 5 in Spain, 3 in Taiwan, 3 in Thailand, 3 in United Kingdom, 18 in United States. Indication: The human papillomaviruses (HPV)-16/18 vaccine is indicated in females from 9 years of age onwards for the prevention of persistent infection, premalignant genital (cervical, vulvar and vaginal) lesions and cervical, vulvar and vaginal cancers (squamous-cell carcinoma and adenocarcinoma) caused by oncogenic HPV types. Treatment: No vaccine was administered during this study. The study group consisted a subset of HPV- subjects who at their last study visit of study HPV- (Visit 10, Month 48) displayed normal cervical cytology but tested positive for oncogenic HPV infection or were pregnant so that no cervical sample could be collected at that visit. Objectives: To provide clinical management and, if required, treatment to subjects who at the end of the HPV- study displayed normal cervical cytology but tested positive for oncogenic HPV infection or to subjects who were pregnant at the end of the HPV- study so that no cervical sample could be collected. To report fatal serious adverse events (SAEs), SAEs related to study participation and SAEs related to a concurrent GSK medication in all subjects. Primary Outcome/Efficacy Variable: Evaluation of the presence of oncogenic HPV DNA in cervical samples by HPV DNA testing (Hybrid Capture 2 test [HCII]). Evaluation of cervical cytological abnormalities in cervical samples by ThinPrep PapTest. Occurrence of referral to colposcopy. Evaluation of colposcopy outcomes and biopsy results according to local laboratories. Occurrence of referrals to treatment. Evaluation of local cervical therapy performed and treatment biopsy results according to local laboratories. Occurrence of fatal SAEs. Occurrence and intensity of SAEs assessed as possibly related to study participation. Occurrence and intensity of SAEs assessed as possibly related to a concurrent GSK medication. Withdrawals from the study due to AEs or SAEs. Secondary Outcome/Efficacy Variable(s): Outcome variables were not differentiated into primary and secondary in the study protocol; all are considered as primary outcome variables for this study. Statistical Methods: The analysis was performed on the Total HPV-052 cohort includes the HPV- subjects who at their last HPV- study visit at Month 48 displayed normal cervical cytology but tested positive for oncogenic HPV infection or who were pregnant so that no cervical sample could be collected at that visit and who attended any visit in this study. Analysis of Safety The analysis of safety was performed on the total HPV-052 cohort The percentage of subjects with oncogenic HPV DNA in cervical samples by HCII, colposcopy referral and adequacy, cervical cytology and biopsy result, treatment referrals and treatment type and their 95% confidence intervals were tabulated at each timepoint. The percentage of subjects with SAEs and SAEs that are possibly related to study participation, a concurrent GSK medication and percentage of subjects with AEs or SAEs leading to withdrawal were tabulated. Study Population: Subset of HPV- study subjects (15-25 years old at first study vaccination), who at their last study visit of HPV- (Visit 10, Month 48) displayed normal cervical cytology but tested positive for oncogenic HPV infection, or were pregnant and hence no cervical sample could be collected at that visit. Written informed consent
2 was obtained from the subjects prior to enrolment. Number of Subjects: Planned, N 2000 Entered, N (Total HPV-052 cohort) 2003 Completed, n (%) 1787 (89.2) Total Number Subjects Withdrawn, n (%) 216 (10.8) Withdrawn due to Adverse Events, n (%) 0 (0.0) Withdrawn due to Lack of Efficacy, n (%) Not Applicable Withdrawn for other reasons, n (%) 216 (10.8) Demographics N (Total HPV-052 cohort) 2003 Sex, n (%) Females 2003 (100) Mean Age, years (SD) 24.3 (3.06) Median Age, years 23.0 Minimum, Maximum (19,32) White/Caucasian, n (%) 1211 (60.5) East & South East Asian, n (%) 549 (27.4) Chinese, n (%) 106 (5.3) Primary Outcome Results: Number (%) of subject with their HPV DNA status by HCII at each yearly study visit (Total HPV-052 cohort) Study Month HPV DNA result N n % LL UL 12 Months post HPV Positive Negative Missing Months post HPV Positive Negative Missing Months post HPV Positive Negative Missing Months post HPV Positive Negative Missing Overall Positive Negative Missing N = number of subjects n = number of subjects in a given category % = n / Number of subjects with available results x 100 LL, UL = Exact 95% Lower and Upper confidence limits Missing = For some of the subjects whose result is QNS Primary Outcome Results: Number (%) of subjects with cervical cytology result at each yearly study visit (Total HPV- 052 cohort) Study Month Cervical cytology result N n % LL UL 12 Months Post HPV Normal ASC-US ASC-H LSIL HSIL AGC
3 24 Months Post HPV Normal ASC-US ASC-H LSIL HSIL AGC Months Post HPV Normal ASC-US ASC-H LSIL HSIL AGC Months Post HPV Normal ASC-US ASC-H LSIL HSIL AGC Overall Normal ASC-US ASC-H LSIL HSIL AGC N = number of subject number n = number of subject number in a given category % = n / Number of subject number with available results x 100 LL, UL = Exact 95% Lower and Upper confidence limits ASC-US = Atypical Squamous Cell of Undetermined Significance LSIL = Low-grade Squamous Intraepithelial Lesions HSIL= High-grade Squamous Intraepithelial Lesions AGC = Atypical Glandular Cells ASC-H = Atypical Squamous Cells cannot exclude HSIL Primary Outcome Results: Number (%) of subjects with colposcopy referral and colposcopy adequacy at each study visit (Total HPV-052 cohort) Study Month Characteristics Categories N n % LL UL 12 Months Post HPV 24 Months Post HPV Colposcopy referral Yes No Missing Algorithm respected* Yes No Colposcopy adequacy* Satisfactory Unsatisfactory Missing Colposcopy referral Yes No Missing Algorithm respected* Yes No Missing
4 36 Months Post HPV 48 Months Post HPV Colposcopy adequacy* Satisfactory Unsatisfactory Missing Colposcopy referral Yes No Missing Algorithm respected* Yes No Colposcopy adequacy* Satisfactory Unsatisfactory Missing Colposcopy referral Yes No Missing Algorithm respected* Yes No Colposcopy adequacy* Satisfactory Unsatisfactory Missing Overall Colposcopy referral Yes No Missing Algorithm respected* Yes No Missing Colposcopy adequacy* Satisfactory Unsatisfactory Missing N = number of subjects n = number of subjects in a given category % = n / Number of subjects with available result x 100 LL, UL = Exact 95% Lower and Upper confidence limits * = number of subjects for whom colposcopy has been performed Primary Outcome Results: Number (%) of cervical biopsy results at each study visit (Total HPV-052 cohort) Study Month Cervical biopsy result Categories N n % LL UL 12 Months Post HPV Negative Only CIN1 Positive Negative Only CIN2 Positive Negative Only CIN3 Positive Negative CIN1 and CIN2 Positive Negative CIN1 and CIN3 Positive Negative CIN2 and CIN3 Positive
5 24 Months Post HPV 36 Months Post HPV Negative CIN1 and CIN2 and CIN3 Positive Negative AIS Positive Negative Invasive malignancy Positive Negative Other Negative Only CIN1 Positive Negative Only CIN2 Positive Negative Only CIN3 Positive Negative CIN1 and CIN2 Positive Negative CIN1 and CIN3 Positive Negative CIN2 and CIN3 Positive Negative CIN1 and CIN2 and CIN3 Positive Negative AIS Positive Negative Invasive malignancy Positive Negative Other Negative Only CIN1 Positive Negative Only CIN2 Positive Negative Only CIN3 Positive Negative CIN1 and CIN2 Positive CIN1 and CIN3 Positive CIN2 and CIN3 Positive CIN1 and CIN2 and CIN3 Positive AIS Positive Invasive malignancy Positive Other
6 48 Months Post HPV Negative Only CIN1 Positive Negative Only CIN2 Positive Negative Only CIN3 Positive Negative CIN1 and CIN2 Positive Negative CIN1 and CIN3 Positive CIN2 and CIN3 Positive CIN1 and CIN2 and CIN3 Positive AIS Positive Invasive malignancy Positive Other Other Overall Negative Only CIN1 Positive Negative Only CIN2 Positive Negative Only CIN3 Positive Negative CIN1 and CIN2 Positive Negative CIN1 and CIN3 Positive Negative CIN2 and CIN3 Positive Negative CIN1 and CIN2 and CIN3 Positive Negative AIS Positive Negative Invasive malignancy Positive Negative Other N = number of subjects for whom cervical biopsy results is available at each visit n = number of subjects in a given category % = n / Number of subjects with available results x 100 CIN1 = Cervical Intraepithelial Neoplasia grade 1 CIN2 = Cervical Intraepithelial Neoplasia grade 2 CIN3 = Cervical Intraepithelial Neoplasia grade 3 AIS = Adenocarcinoma in situ Note: Only CIN1/Only CIN2/Only CIN3 categories contain the subject who has only CIN1/CIN2/CIN3 but not the combinations.
7 Primary Outcome Results: Number (%) of subjects with treatment referrals and treatment type according to local medical practice (Total HPV-052 cohort) Study Month Characteristics Categories N n % LL UL 12 Months Post HPV 24 Months Post HPV 36 Months Post HPV 48 Months Post HPV Treatment referral Yes No Loop excision of cervix Yes No Loop cone of cervix Yes No Cold knife cone of cervix Yes No Laser excision Yes No Other Treatment referral Yes No Missing Loop excision of cervix Yes No Loop cone of cervix Yes No Cold knife cone of cervix Yes No Laser excision Yes No Other Treatment referral Yes No Loop excision of cervix Yes No Loop cone of cervix Yes No Cold knife cone of cervix Yes No Laser excision Yes No Other Treatment referral Yes No Loop excision of cervix Yes No Loop cone of cervix Yes No Cold knife cone of cervix Yes No Laser excision Yes No Other Overall Treatment referral Yes No Missing Loop excision of cervix Yes No Loop cone of cervix Yes
8 No Cold knife cone of cervix Yes No Laser excision Yes No Other N = number of subjects n = number of subjects in a given category % = n / Number of subjects with available results x 100 LL, UL = Exact 95% Lower and Upper confidence limits Primary Outcome Results: Number of subjects with AEs or SAEs leading to withdrawal throughout the study (Total HPV-052 cohort) HPV-052 Study Group N = 2003 Number of subjects withdrawn, n (%) 216 (10.8) Reasons for withdrawal, n (%) Serious Adverse Event 0 (0.0) Non-Serious Adverse Event 0 (0.0) Safety Results: Number (%) of subjects with any fatal SAE, study participation or GSK concomitant medication (Total HPV-052 cohort) Serious Adverse Events, n (%) [n considered by the investigator to be related to study medication] All SAEs HPV-052 Study Group N = 2003 Subjects with any SAEs, n (%) [n assessed by the investigator as related] 0 (0.0) [0] HPV-052 Study Group N = 2003 Subjects with fatal SAEs, n (%) [n assessed by the investigator as related] 0 (0.0) [0] Conclusion: This study provided clinical management and treatment when required to the subjects who at the end of the HPV- study displayed normal cervical cytology but tested positive for oncogenic HPV infections or to subjects who were pregnant at the end of the HPV- study so no cervical sample could be collected. Throughout the 4-year follow-up, 820 subjects [41.2%, : 19.3%, 21.9%] tested as HPV-DNA positive by HCII in at least one of their cytology samples. The majority of the subjects [91.0%, : 89.7%, 92.2%] had normal cytology. Seven hundred and sixty five [38.2%, : 36.1%, 40.4%] subjects were referred to a colposcopy examination, and 58 subjects [9.3%, : 7.1%, 11.9%] were referred for a treatment, according to local medical practice. There were no SAEs with fatal outcome or related to the study participation or related to the concomitant GSK medications reported during the study period. No subjects withdrew from study due to an AE or SAE. Date updated: 13-September-2017
GSK Medication: Study No.: Title: Rationale: Phase: Study Period Study Design: Centres: Indication: Treatment: Objectives:
The study listed may include approved and non-approved uses, formulations or treatment regimens. The results reported in any single study may not reflect the overall results obtained on studies of a product.
More informationStudy No.: Title: Rationale: Phase: Study Period: Study Design: Centers: Indication: Treatment: Objectives: Primary Outcome/Efficacy Variable:
The study listed may include approved and non-approved uses, formulations or treatment regimens. The results reported in any single study may not reflect the overall results obtained on studies of a product.
More informationUnderstanding Your Pap Test Results
Understanding Your Pap Test Results Most laboratories in the United States use a standard set of terms called the Bethesda System to report pap test results. Normal: Pap samples that have no cell abnormalities
More informationAppropriate Use of Cytology and HPV Testing in the New Cervical Cancer Screening Guidelines
Appropriate Use of Cytology and HPV Testing in the New Cervical Cancer Screening Guidelines Tim Kremer, MD Ralph Anderson, MD 1 Objectives Describe the natural history of HPV particularly as it relates
More informationFaculty Pap Smear Guidelines: Family Planning Update 2008 Part Two
Faculty Pap Smear Guidelines: Family Planning Update 2008 Part Two Seshu P. Sarma, MD, FAAP Emory University Regional Training Center Atlanta, Georgia Produced by the Alabama Department of Public Health
More informationDysplasia: layer of the cervical CIN. Intraepithelial Neoplasia. p16 immunostaining. 1, Cervical. Higher-risk, requires CIN.
CLINICAL PRACTICE GUIDELINE Guideline Number: DHMP_DHMC_PG1015 Guideline Subject: Routine Cervical Cancer Screening Effective Date: 9/2018 Revision Date: 9/2019 Pages: 2 of 2 Quality Management Committee
More informationBC Cancer Cervix Screening 2015 Program Results. February 2018
BC Cancer Cervix Screening 2015 Program Results BC Cancer Cervix Screening 2015 Program Results 2 Table of Contents BC Cancer Cervix Screening 2015 Program Results... 1 Table of Contents... 2 Program Overview...
More informationCervical Screening for Dysplasia and Cancer in Patients with HIV
Cervical Screening for Dysplasia and Cancer in Patients with HIV Adult Clinical Guideline from the New York State Department of Health AIDS Institute w w w.hivg uidelines.org Purpose of the Guideline Increase
More informationChapter 10: Pap Test Results
Chapter 10: Pap Test Results On completion of this section, the learner will be able to: 1. Identify how Pap test results are interpreted and the reasons for normal and abnormal results. 2. Describe the
More informationEradicating Mortality from Cervical Cancer
Eradicating Mortality from Cervical Cancer Michelle Berlin, MD, MPH Vice Chair, Obstetrics & Gynecology Associate Director, Center for Women s Health June 2, 2009 Overview Prevention Human Papilloma Virus
More informationManagement Algorithms for Abnormal Cervical Cytology and Colposcopy
Management Algorithms for Abnormal Cervical Cytology and Colposcopy Table of Contents Standard Colposcopic Definitions... 1 Guidelines for the Assessment of Abnormal Cervical Cytology... 2 Ia: Persistent
More informationCervical Testing and Results Management. An Evidenced-Based Approach April 22nd, Debora Bear, MSN, MPH
Cervical Testing and Results Management An Evidenced-Based Approach April 22nd, 2010 Debora Bear, MSN, MPH Assistant Medical Director for Planned Parenthood of New Mexico, Inc. Burden of cervical cancer
More informationStudy No.: Title: Rationale: Phase: Study Period: Study Design: Centres: Indication: Treatment: Objectives: Primary Outcome/Efficacy Variable:
he study listed may include approved and non-approved uses, formulations or treatment regimens. The results reported in any single study may not reflect the overall results obtained on studies of a product.
More information!"#$%&'(#)*$+&,$-&.#,$/#0()1-$ ),1')$2(%&,2#,%$%(0'#$34567$
!"#$%&'(#)*$+&,$-&.#,$/#0()1-$ ),1')$2(%&,2#,%$%(0'#$34567$ Updated Consensus Guidelines for Managing Abnormal Cervical Cancer Screening Tests and Cancer Precursors American Society for and Cervical Pathology
More informationManagement of Abnormal Cervical Cytology and Histology
Management of Abnormal Cervical Cytology and Histology Assoc. Prof. Gökhan Tulunay Etlik Zübeyde Hanım Women s Diseases Teaching & Research Hospital Gynecologic Oncology Clinic Universally accepted guideline
More informationMaking Sense of Cervical Cancer Screening
Making Sense of Cervical Cancer Screening New Guidelines published November 2012 Tammie Koehler DO, FACOG The incidence of cervical cancer in the US has decreased more than 50% in the past 30 years because
More informationCase Based Problems. Recommended Guidelines. Workshop: Case Management of Abnormal Pap Smears and Colposcopies. Disclosure
Disclosure Workshop: Case Management of Abnormal Pap Smears and Colposcopies Rebecca Jackson, MD Associate Professor Obstetrics, Gynecology & Reproductive Sciences and Epidemiology & Biostatistics This
More informationThe society for lower genital tract disorders since 1964.
The society for lower genital tract disorders since 1964. Updated Consensus Guidelines for Managing Abnormal Cervical Cancer Screening Tests and Cancer Precursors American Society for and Cervical Pathology
More informationCervical Cancer Screening. David Quinlan December 2013
Cervical Cancer Screening David Quinlan December 2013 Cervix Cervical Cancer Screening Modest variation provincially WHO and UK begin at 25 stop at 60 Finland begin at 30 stop at 60 Rationale for
More informationScreening for Cervical Cancer: Demystifying the Guidelines DR. NEERJA SHARMA
Screening for Cervical Cancer: Demystifying the Guidelines DR. NEERJA SHARMA Cancer Care Ontario Cervical Cancer Screening Goals Increase patient participation in cervical screening Increase primary care
More informationColposcopy. Attila L Major, MD, PhD
Colposcopy Attila L Major, MD, PhD Histology Colposcopy Cytology It has been estimated that annual Pap smear testing reduces a woman s chance of dying of cervical cancer from 4 in 1000 to about 5 in 10,000
More informationHBV-2 Group: neonates born to HBsAg+ and HBeAg+ mothers who received a 4-dose vaccination regimen (Part of
The study listed may include approved and non-approved uses, formulations or treatment regimens. The results reported in any single study may not reflect the overall results obtained on studies of a product.
More informationCervical Dysplasia and HPV
Cervical Dysplasia and HPV J. Anthony Rakowski D.O., F.A.C.O.O.G. MSU SCS Board Review Coarse HPV Double stranded DNA virus The HPV infect epithelial cells of the skin and mucous membranes Highest risk
More informationStudy No.: Title: Rationale: Phase: Study Period: Study Design: Center: Indication: Treatment: Objective: Primary Outcome/Efficacy Variable:
The study listed may include approved and non-approved uses, formulations or treatment regimens. The results reported in any single study may not reflect the overall results obtained on studies of a product.
More informationStudy No.: Title: Rationale: Phase: Study Period: Study Design: Center: Indication: Treatment: Objectives:
The study listed may include approved and non-approved uses, formulations or treatment regimens. The results reported in any single study may not reflect the overall results obtained on studies of a product.
More informationCERVICAL CANCER SCREENING SCENARIOS for pan-canadian Cervical Screening Initiative
CERVICAL CANCER SCREENING SCENARIOS for pan-canadian Cervical Screening Initiative June 18 2014 Acknowledgements Anthony Miller Cathy Popadiuk Claude Nadeau Keiko Asakawa Marc Brisson Michael Wolfson Saima
More informationsubjects having anti-hav antibody concentrations 100 miu/ml at the pre- additional vaccination time point.
The study listed may include approved and non-approved uses, formulations or treatment regimens. The results reported in any single study may not reflect the overall results obtained on studies of a product.
More informationCervical Cancer Screening for the Primary Care Physician for Average Risk Individuals Clinical Practice Guidelines. June 2013
Cervical Cancer Screening for the Primary Care Physician for Average Risk Individuals Clinical Practice Guidelines General Principles: Since its introduction in 1943, Papanicolaou (Pap) smear is widely
More informationClinical Guidance: Recommended Best Practices for Delivery of Colposcopy Services in Ontario Best Practice Pathway Summary
Clinical Guidance: Recommended Best Practices for Delivery of Colposcopy Services in Ontario Best Practice Pathway Summary Glossary of Terms Colposcopy is the examination of the cervix, vagina and, in
More informationFor the additional vaccination phase
The study listed may include approved and non-approved uses, formulations or treatment regimens. The results reported in any single study may not reflect the overall results obtained on studies of a product.
More informationWoo Dae Kang, Ho Sun Choi, Seok Mo Kim
Is vaccination with quadrivalent HPV vaccine after Loop Electrosurgical Excision Procedure effective in preventing recurrence in patients with High-grade Cervical Intraepithelial Neoplasia (CIN2-3)? Chonnam
More informationStudy No.: Title: Rationale: Phase: Study Period: Study Design: Centres: Indication: Treatment: Objectives: Primary Outcome/Efficacy Variable:
The study listed may include approved and non-approved uses, formulations or treatment regimens. The results reported in any single study may not reflect the overall results obtained on studies of a product.
More informationClinical Practice Guidelines June 2013
Clinical Practice Guidelines June 2013 General Principles: The Papanicolaou (Pap) smear is widely credited with reducing mortality from cervical cancer, and remains the single best method for the early
More informationStudy No.: Title: Rationale: Phase: Study Period: Study Design: Centers: Indication Treatment: Objectives: Primary Outcome/Efficacy Variable:
The study listed may include approved and non-approved uses, formulations or treatment regimens. The results reported in any single study may not reflect the overall results obtained on studies of a product.
More informationSupplementary Appendix
Supplementary Appendix This appendix has been provided by the authors to give readers additional information about their work. Supplement to: Garland SM, Hernandez-Avila M, Wheeler CM, et al. Quadrivalent
More informationI have no financial interests in any product I will discuss today.
Cervical Cancer Prevention: 2012 and Beyond George F. Sawaya, MD Professor Department of Obstetrics, Gynecology and Reproductive Sciences Department of Epidemiology and Biostatistics University of California,
More informationASCCP 2013 Guidelines for Managing Abnormal Cervical Cancer Screening Tests
ASCCP 2013 Guidelines for Managing Abnormal Cervical Cancer Screening Tests www.treatmentok.com Barbara S. Apgar, MD, MS Professor of Family Medicine University of Michigan Ann Arbor, Michigan Disclosures
More informationClinical outcomes after conservative management of CIN1/2, CIN2, and CIN2/3 in women ages years
Clinical outcomes after conservative management of CIN1/2, CIN2, and CIN2/3 in women ages 21-39 years Michelle I. Silver, PhD, ScM Cancer Prevention Fellow National Cancer Institute Division of Cancer
More informationThe new Cervical Screening Test for Australian women: Louise Farrell
The new Cervical Screening Test for Australian women: Louise Farrell Outline and explain the changes to the National Cervical Screening Program due to commence in Dec 2017 LEARNING OBJECTIVES FOR TODAY
More informationNational Cervical Screening Program MBS Item Descriptors
National Cervical Screening Program MBS Item Descriptors Item Item descriptor 73070 A test, including partial genotyping, for oncogenic human papillomavirus that may be associated with cervical pre-cancer
More informationCuid d Fheidhmeannacht na Seirbhíse Sláinte. Part of the Health Service Executive. CS/PR/PM-20 Rev 2 ISBN Programme Report 2014/2015
Programme Report 2014/2015 Contents Summary points 2 Introduction to the statistics 2014/2015 3 Part 1 Cervical screening activity 3 Programme coverage 4 Laboratory turnaround time 7 Notification of results
More informationGSK Medicine: Study Number: Title: Rationale: Phase: Study Period: Study Design: Centres: Indication: Treatment: Objectives:
The study listed may include approved and non-approved uses, formulations or treatment regimens. The results reported in any single study may not reflect the overall results obtained on studies of a product.
More informationStudy No.: Title: Rationale: Phase: Study Period: Study Design: Centres: Indication: Treatment: Objectives: Primary Outcome/Efficacy Variable:
The study listed may include approved and non-approved uses, formulations or treatment regimens. The results reported in any single study may not reflect the overall results obtained on studies of a product.
More informationLong-term follow-up at Month 198: 21 October 2008 to 07 December Long-term follow-up at Month 186: 01 October 2007 to 19 December 2008
The study listed may include approved and non-approved uses, formulations or treatment regimens. The results reported in any single study may not reflect the overall results obtained on studies of a product.
More informationManitoba Cervical Cancer Screening Program. Operations & Statistical Report and 2006
anitoba Cervical Cancer Screening Program Operations & Statistical Report 2005 and 2006 1 MCCSP 2005-2006 Report ANITOBA CERVICAL CANCER SCREENING PROGRAM 2005 and 2006 Operations & Statistical Report
More informationI have no financial interests in any product I will discuss today.
Cervical Cancer Screening Update and Implications for Annual Exams George F. Sawaya, MD Professor Department of Obstetrics, Gynecology and Reproductive Sciences Department of Epidemiology and Biostatistics
More informationHPV and Cervical Cancer, Screening and Prevention. John Ragsdale, MD July 12, 2018 CME Lecture Series
HPV and Cervical Cancer, Screening and Prevention John Ragsdale, MD July 12, 2018 CME Lecture Series We have come a long Way Prevalence HPV in Young Adults in U.S HPV genotypes 55-60% of All cancers 20%
More informationLessons From Cases of Screened Women Who Developed Cervical Carcinoma
Lessons From Cases of Screened Women Who Developed Cervical Carcinoma R. Marshall Austin MD,PhD Magee-Womens Hospital of University of Pittsburgh Medical Center raustin@magee.edu Why Focus Study On Cases
More informationI have no financial interests to disclose.
Workshop: Case Management of Abnormal Pap Smears and Colposcopies Rebecca Jackson, MD Professor Obstetrics, Gynecology & Reproductive Sciences and Epidemiology & Biostatistics I have no financial interests
More informationI have no financial interests in any product I will discuss today.
Cervical Cancer Screening Update and Implications for Annual Exams George F. Sawaya, MD Professor Department of Obstetrics, Gynecology and Reproductive Sciences Department of Epidemiology and Biostatistics
More informationThe study listed may include approved and non-approved uses, formulations or treatment regimens. The results reported in any single study may not
The study listed may include approved and non-approved uses, formulations or treatment regimens. The results reported in any single study may not reflect the overall results obtained on studies of a product.
More informationDone by khozama jehad. Neoplasia of the cervix
Done by khozama jehad Neoplasia of the cervix An overview of cervical neoplasia very import. Most tumors of the cervix are of epithelial origin and are caused by oncogenic strains of human papillomavirus
More informationStreamlining Protocols-From Strategy to Implementation. Doreen Ramogola-Masire Botswana UPenn Partnership June 2014
Streamlining Protocols-From Strategy to Implementation Doreen Ramogola-Masire Botswana UPenn Partnership 18-20 June 2014 Botswana-UPenn Partnership Partnership between Government of Botswana, University
More informationYour Colposcopy Visit
Introduction Welcome to the colposcopy clinic. This booklet tells you about. The colposcopy examination.. Tests that are done in the colposcopy clinic.. What these tests look for Take a few minutes to
More informationHuman Papillomaviruses and Cancer: Questions and Answers. Key Points. 1. What are human papillomaviruses, and how are they transmitted?
CANCER FACTS N a t i o n a l C a n c e r I n s t i t u t e N a t i o n a l I n s t i t u t e s o f H e a l t h D e p a r t m e n t o f H e a l t h a n d H u m a n S e r v i c e s Human Papillomaviruses
More informationScreening for the Precursors of Cervical Cancer in the Era of HPV Vaccination. Dr Stella Heley Senior Liaison Physician Victorian Cytology Service
Screening for the Precursors of Cervical Cancer in the Era of HPV Vaccination Dr Stella Heley Senior Liaison Physician Victorian Cytology Service Victorian Cytology Service Dr Stella Heley Dr Siobhan Bourke
More informationObjectives. I have no financial interests in any product I will discuss today. Cervical Cancer Screening Guidelines: Updates and Controversies
Cervical Cancer Screening Guidelines: Updates and Controversies I have no financial interests in any product I will discuss today. Jody Steinauer, MD, MAS University of California, San Francisco Objectives
More informationStudy No.: Title: Rationale: Phase: Study Period: Study Design: Centres: Indication: Treatment: Objectives: Primary Outcome/Efficacy Variable:
The study listed may include approved and non-approved uses, formulations or treatment regimens. The results reported in any single study may not reflect the overall results obtained on studies of a product.
More informationHKCOG GUIDELINES NUMBER 3 (revised November 2002) published by The Hong Kong College of Obstetricians and Gynaecologists
HKCOG Guidelines Guidelines on the Management of An Abnormal Cervical Smear Number 3 revised November 2002 published by The Hong Kong College of Obstetricians and Gynaecologists A Foundation College of
More informationHuman Papillomavirus. Kathryn Thiessen, ARNP, ACRN The Kansas AIDS Education and Training Center The University of Kansas School of Medicine Wichita
Human Papillomavirus Kathryn Thiessen, ARNP, ACRN The Kansas AIDS Education and Training Center The University of Kansas School of Medicine Wichita What is Genital HPV Infection Human papillomavirus is
More informationPortinari: A Data Exploration Tool to Personalize Cervical Cancer Screening
Portinari: A Data Exploration Tool to Personalize Cervical Cancer Screening Sagar Sen, Manoel Horta Ribeiro, Raquel C. de Melo Minardi, Wagner Meira Jr., Mari Nygård Certus V&V Center and HPV Research
More informationCervical Skills. Dr Margaret Laing Queen Elizabeth University Hospital
Cervical Skills Dr Margaret Laing Queen Elizabeth University Hospital What is screening? Screening is a test offered to an apparently well person with the possibility of detecting a serious disease before
More informationBecoming a colposcopist: Colposcope case studies
Becoming a colposcopist: Colposcope case studies Seon-Kyung Lee, M.D. Department of Obstetrics and Gynecology College of Medicine, Kyung Hee University Value of Colposcopy Cytology is an effective screening
More informationStudy No.: Title: Rationale: Phase: Study Period: Study Design: Centers: Indication: Treatment: Objectives:
The study listed may include approved and non-approved uses, formulations or treatment regimens. The results reported in any single study may not reflect the overall results obtained on studies of a product.
More informationStudy No.: Title: Rationale: Phase: Study Period: Study Design: Centres: Indication: Treatment: Objective: Primary Outcome/Efficacy Variables:
The study listed may include approved and non-approved uses, formulations or treatment regimens. The results reported in any single study may not reflect the overall results obtained on studies of a product.
More informationDisclosures. Learning objectives. George F. Sawaya, MD. I have nothing to disclose.
Well Woman Visits in 2018: How Should We Approach Cervical Cancer Screening and Routine Pelvic Examinations? George F. Sawaya, MD Disclosures I have nothing to disclose. Professor, Obstetrics, Gynecology
More informationStudy No.: Title: Rationale: Phase: Study Period: Study Design: Centers: Indication: Treatment: Objectives: Primary Outcome/Efficacy Variable:
The study listed may include approved and non-approved uses, formulations or treatment regimens. The results reported in any single study may not reflect the overall results obtained on studies of a product.
More informationGUIDELINE FOR SCREENING FOR CERVICAL CANCER: REVISED
GUIDELINE FOR SCREENING FOR CERVICAL CANCER: REVISED This guideline is a revised version of the guideline developed in February 2000, by the Cervical Cancer Screening Working Group. This revised version
More informationStudy No.: Title: Rationale: Phase: Study Period: Study Design: Centers: Indication: Treatment: Objectives: Primary Outcome/Efficacy Variable:
The study listed may include approved and non-approved uses, formulations or treatment regimens. The results reported in any single study may not reflect the overall results obtained on studies of a product.
More informationcle Modern management of abnormal cervical smear Tint Tint Wai and Dilip Patil BJMP 2008:1(2) 18-22
BJMP 2008:1(2) 18-22 Review Articl cle Modern management of abnormal cervical smear Tint Tint Wai and Dilip Patil Abbreviations BSCCP British Society of Colposcopy and Cervical Pathology CIN Cervical intraepithelial
More informationAtypical Glandular Cells of Undetermined Significance Outcome Predictions Based on Human Papillomavirus Testing
Anatomic Pathology / ATYPICAL GLANDULAR CELLS AND HUMAN PAPILLOMAVIRUS Atypical Glandular Cells of Undetermined Significance Outcome Predictions Based on Human Papillomavirus Testing Jeffrey F. Krane,
More informationManagament of Abnormal Cervical Cytology and Histology
Managament of Abnormal Cervical Cytology and Histology Ali Ayhan, M.D Başkent University Faculty of Medicine Department of Gynecology and Obstetrics Division of Gynecologic Oncology Abnormal Cytologic
More informationBiomed Environ Sci, 2015; 28(1): 80-84
80 Biomed Environ Sci, 2015; 28(1): 80-84 Letter to the Editor Assessing the Effectiveness of a Cervical Cancer Screening Program in a Hospital-based Study* YANG Yi1, LANG Jing He1, WANG You Fang1, CHENG
More informationAnalysis of immunogenicity
The study listed may include approved and non-approved uses, formulations or treatment regimens. The results reported in any single study may not reflect the overall results obtained on studies of a product.
More informationAlthough rare, a significant increase in incidence
Original Research Concurrent Anal Human Papillomavirus and Abnormal Anal Cytology in Women With Known Cervical Dysplasia Jacqueline Lammé, MD, Tina Pattaratornkosohn, MD, Joselyn Mercado-Abadie, MD, Addie
More informationPOST-CONIZATION FOLLOW-UP OF PATIENTS WITH HIGH GRADE SQUAMOUS INTRAEPITHELIAL LESION TREATED BY LEEP PROCEDURE: A LITERATURE REVIEW
POST-CONIZATION FOLLOW-UP OF PATIENTS WITH HIGH GRADE SQUAMOUS INTRAEPITHELIAL LESION TREATED BY LEEP PROCEDURE: A LITERATURE REVIEW Boureima Ali Nafissatou and Dong zhao * Department of Gynecology, Shanghai
More informationEU guidelines for reporting gynaecological cytology
EU guidelines for reporting gynaecological cytology Amanda Herbert Guy s & St Thomas Foundation NHS Trust 5th EFCS Annual Tutorial, Trondheim, Norway 28 th May 1 st June 2012 EU guidelines aim to harmonize
More informationPREINVASIVE DISEASE OF THE LOWER GENITAL TRACT DR AI LING TAN GYNAECOLOGICAL ONCOLOGIST ASCOT CLINIC,ADHB
PREINVASIVE DISEASE OF THE LOWER GENITAL TRACT DR AI LING TAN GYNAECOLOGICAL ONCOLOGIST ASCOT CLINIC,ADHB HPV 200 types HR 16,18 LR 6,11 IARC 1 ASSOCIATION BETWEEN HPV DNA AND RISK OF S.C. CANCER CERVIX
More informationNo Disclosures. Updated Guidelines for Cervical Cancer Screening and Prevention Management of Abnormal Results. Objectives 5/9/2016
Updated Guidelines for Cervical Cancer Screening and Prevention Management of Abnormal Results Kathy A. King, MD Assistant Professor of OB/GYN Medical Director, PPWI Medical College of Wisconsin May 6,
More informationCervical Conization. 1
Cervical Conization www.zohrehyousefi.com 1 Cone Biopsy is a surgical procedure with removal of a cone shaped portion of the cervix The extent of involvement of epithelium on the ectocervix has been clearly
More informationFocus. International #52. HPV infection in High-risk HPV and cervical cancer. HPV: Clinical aspects. Natural history of HPV infection
HPV infection in 2014 Papillomaviruses (HPV) are non-cultivable viruses with circular DNA. They can establish productive infections in the skin (warts) and in mucous membranes (genitals, larynx, etc.).
More informationCERVICAL INTRAEPITHELIAL NEOPLASIA (CIN)
CERVICAL INTRAEPITHELIAL NEOPLASIA (CIN) The cervix constitutes the lower third of the uterus. It is in two parts, the endocervix and the ectocervix. Ectocervix is covered with squamous epithelium. Endocervix
More informationCytology Update M Laing QEUH
Cytology Update M Laing QEUH Age change to 25 to 65 Age 25 to 50 Three yearly smear invitation Age 50 to 65 Five yearly smear invitation Women on non routine screening will be invited up to age 70 OUTCOME
More informationCervical Cancer Screening Update. Melissa Hartman, DO Women s Health
Cervical Cancer Screening Update Melissa Hartman, DO Women s Health Previous Cervical Cancer Screening Organization Recommendation ACS (2011) ACP (2008) NCI (2003) Age 21 or 3 years after first intercourse
More informationCervical Screening Results Leading to Detection of Adenocarcinoma in Situ of the Uterine Cervix
DOI:10.31557/APJCP.2019.20.2.377 Cervical Screening Results Leading to Detecting Cervical AIS RESEARCH ARTICLE Editorial Process: Submission:09/27/2018 Acceptance:01/18/2019 Cervical Screening Results
More informationImplementation of a Research-Robust Colposcopy Management Program within the Electronic Medical Record System
Implementation of a Research-Robust Colposcopy Management Program within the Electronic Medical Record System Lonky NM*, Cannizzaro N, Xu L, Castaneda A, Stowe T, Hawk S, Chao C Southern California Permanente
More informationCervical Cancer 4/27/2016
Guidelines for Cervical Cancer Screening and Prevention Management of Abnormal Results Kathy A. King, MD Assistant Professor of OB/GYN Medical College of Wisconsin May 6, 2016 Cervical Cancer In US about
More informationP16 et Ki67 Biomarkers: new tool for risk management and low grade intraepithelial lesions (LGSIL): be ready for the future.
P16 et Ki67 Biomarkers: new tool for risk management and low grade intraepithelial lesions (LGSIL): be ready for the future. Mark H Stoler, MD University of Virginia Health System, Charlottesville, VA,
More information1.Acute and Chronic Cervicitis - At the onset of menarche, the production of estrogens by the ovary stimulates maturation of the cervical and vaginal
Diseases of cervix I. Inflammations 1.Acute and Chronic Cervicitis - At the onset of menarche, the production of estrogens by the ovary stimulates maturation of the cervical and vaginal squamous mucosa
More informationGSK Medicine: Study Number: Title: Rationale: Phase: Study Period Study Design: Centres: Indication: Treatment: Objectives:
The study listed may include approved and non-approved uses, formulations or treatment regimens. The results reported in any single study may not reflect the overall results obtained on studies of a product.
More informationUpdated ASCCP Consensus Guidelines For Managing Diagnosed Cervical Cancer Precursors Michael A. Gold, M.D.
Updated ASCCP Consensus Guidelines For Managing Diagnosed Cervical Cancer Precursors Michael A. Gold, M.D. 27 May, 2014 London, England Faculty Disclosure X No, nothing to disclose Yes, please specify
More informationDepartment of Health Standard for the Cervical Cancer Screening Program. Approval Date: 08 May 2018 Effective Date: 13 May 2018
Document Title: Department of Health Standard for the Cervical Cancer Screening Program Document Ref. Number: DOH/CCSC/SD/1.0 Version: 1.0 Approval Date: 08 May 2018 Effective Date: 13 May 2018 Last Reviewed:
More informationManagement that provides continuity of care for women
Management that provides continuity of care for women If women are diagnosed with reproductive tract infection, prompt treatment should be instituted according to the WHO guidelines. Though it may be preferred
More informationCervical Cancer Screening
Todd R. Jenkins, MD, MSHA Senior Vice Chair Director, Division of Women s Reproductive Healthcare Learning Objectives Describe the etiology, natural history, and usage of the human papillomavirus (HPV)
More informationTISSUE TUMOR MARKER EXPRESSION IN
TISSUE TUMOR MARKER EXPRESSION IN NORMAL CERVICAL TISSUE AND IN CERVICAL INTRAEPITHELIAL NEOPLASIA, FOR WOMEN WHO ARE AT HIGH RISK OF HPV (HUMAN PAPILLOMA VIRUS INFECTION). Raghad Samir MD PhD Verksamhet
More informationSamuel B. Wolf, D.O., F.A.C.O.G. Emerald Coast Obstetrics and Gynecology Panama City Florida
Making sense of the new Pap smear screening guidelines. Samuel B. Wolf, D.O., F.A.C.O.G. Emerald Coast Obstetrics and Gynecology Panama City Florida Case 17 year old G1P0010 with first sexual encounter
More informationShould Anal Pap Smears Be a Standard of Care in HIV Management?
Should Anal Pap Smears Be a Standard of Care in HIV Management? Gordon Dickinson, M.D., FACP Professor of Medicine and Chief Infectious Diseases, Miller School of Medicine Short Answer: NO But 15-20 HPV
More informationProposed New Guidelines for the Management of Women with Abnormal Cervical Smears DRAFT FOR COMMENT
Proposed New Guidelines for the Management of Women with Abnormal Cervical Smears DRAFT FOR COMMENT National Cervical Screening Programme National Screening Unit Ministry of Health October 2006 Table of
More informationVaginal intraepithelial neoplasia
Vaginal intraepithelial neoplasia The terminology and pathology of VAIN are analogous to those of CIN (VAIN I-III). The main difference is that vaginal epithelium does not normally have crypts, so the
More informationCervical Precancer: Evaluation and Management
TAJ June 2002; Volume 15 Number 1 ISSN 1019-8555 The Journal of Teachers Association RMC, Rajshahi Review fam Cervical Precancer: Evaluation and Management SM Khodeza Nahar Begum 1 Abstract Carcinoma of
More information