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1 Clinical Trial Details (PDF Generation Date :- Wed, 10 Oct :19:24 GMT) CTRI Number Last Modified On 06/11/2012 Post Graduate Thesis Type of Trial Type of Study Study Design Public Title of Study Scientific Title of Study CTRI/2012/07/ [Registered on: 13/07/2012] - Trial Registered Retrospectively No Observational Cross Sectional Study Other A study to look for awareness in females towards cervical cancer prevention A study to evaluate willingness in females for daughters HPV vaccination after self screening for HPV infection. Secondary IDs if Any Secondary ID Identifier Details of Principal Investigator or overall Trial Coordinator (multi-center study) Details Contact Person (Scientific Query) Details Contact Person (Public Query) NIL Designation Affiliation NIL Details of Principal Investigator Mustafa Pardiwala Project manager Phone Fax Designation Affiliation GVK Biosciences Pvt. Ltd., 2nd Floor, International Airport Ltd Terminal 1B, Domestic Airport Vile Parle, India mustafa.pardiwala@gvkbio.com Details Contact Person (Scientific Query) Narendra Patil Medical Advisor Phone Fax Designation Affiliation 10th Floor, Platina, Plot No. C 59, G Block, Bandra Kurla Complex, Bandra (E), India narendra_patil@merck.com Details Contact Person (Public Query) Narendra Patil Medical Advisor Phone th Floor, Platina, Plot No. C 59, G Block, Bandra Kurla Complex, Bandra (E), India page 1 / 9

2 Source of Monetary or Material Support Primary Sponsor Details of Secondary Sponsor Countries of Recruitment Sites of Study Fax > MSD Pharmaceuticals Pvt. Ltd Type of Sponsor NIL List of Countries India of Principal Investigator Dr Jayanta Gupta Source of Monetary or Material Support Primary Sponsor Details MSD Pharmaceuticals Pvt Ltd Platina, Plot No. C 59, G Block, Bandra Kurla Complex, Bandra east, Maharashtra Pharmaceutical industry-global NIL of Site Site Phone/Fax/ Apollo gleaneagles hospital Consultant gynecologist, Apollo Gleneagles Hospital, 58, canal circular road,kolkata Kolkata WEST BENGAL jkg.apollo@gmail.com Dr Ranajit Mandal CNCI hospital dept of Gynecological oncology,chittranjan national cancer institute, 37, sp mukherjee road, kolkata Kolkata WEST BENGAL kranajitmandal@yahoo. co.in Dr Vanita Raut Hiranandani Hospital Consultant obs and gynec,hiranandani hospital, hillside avenue,hiranandani garden, powai, mumbai vanitaraut@gmail.com Dr Anahita Chauhan KEM hospital Dept of obstetrics and gynecology,kem hospital,acharya Donde anahitachauhan@gmail Marg, Parel,.com Dr Renu Makkar Makkar medical center Consultant obs and gyn, Makkar medical centre, 3c tilak marg, Lucknow Lucknow UTTAR PRADESH renumakker@yahoo.co m Dr Seema Sharma MGM hospital Dept. of obstetrics and gynecology, Mahatma gandhi medical college and hospital, RIICO industrial area, sitapura, tonk road, jaipur. Jaipur clinicalresearch@mgmc h.org page 2 / 9

3 Details of Ethics Committee RAJASTHAN Dr Atul Munshi Munshi hospital Consultant gynecologist, Munshi Hospital,50, PRITAMNAGAR, AHMEDABAD Ahmadabad GUJARAT Dr Vandana Amin Nidhi Hospital Consultant obs and gynec,nidhi hospital, shreekunj, stadium commerce road, navrangpura, ahmedabad Ahmadabad GUJARAT Dr Asha Kumar Pace clinical research Consultant gynecologist,pace Clinical Research,c/o pranav diabetes centre,57/1,nanda complex, rammurthy nagar main road, Bangalore Bangalore KARNATAKA Dr Ritu Joshi Private clinic Ashish, A 75, Bhabha marg, Tilak nagar, Jaipur Jaipur RAJASTHAN Dr Sunitha Singhvi Singhvi clinic Singhvi Clinic,No 127,Mint street,sowcar pet,chennai Chennai TAMIL NADU munshiap@gmail.com vandanaamin@hotmail. com ashavkumari@gmail.co m ritujoshi01@rediffmail.c om sunitha201275@yahoo. com Dr Anupama Suresh Vinayak Hospital Consultant obs and gynec, Vinayak Hospital & Research Center,PO box no 717, Karangalpady, Mangalore Dakshina Kannada KARNATAKA dranupamasureshy@ya hoo.co.in of Committee Approval Status Date of Approval Is Independent Ethics Committee? ethics_bangalore_dr Anupama ethics_bangalore_dr Asha ethics_bangalore_dr Munshi ethics_bangalore_dr Sunitha Approved 19/11/2011 Yes Approved 05/11/2011 Yes Approved 18/02/2012 Yes Approved 21/11/2011 Yes page 3 / 9

4 Regulatory Clearance Status from DCGI Health Condition / Problems Studied Intervention / Comparator Agent Inclusion Criteria Exclusion Criteria ethics_bangalore_dr Vandana EC for research on human subjects_kem hosp_dr Anahita EC of Hiranandani hospital_hiranandani hospital_dr Raut IEC Apollo gleaneagles hospital_dr Gupta Approved 21/11/2011 Yes Approved 07/07/2012 No Approved 19/11/2011 No Approved 03/12/2011 No IEC_CNCI_Dr Mandal Approved 30/01/2012 No IEC_MGM hospital_dr Seema Sandeep medical IEC_Lucknow_dr makkar Swasthya kalyan IEC_Jaipur_Dr Joshi Status Health Type Healthy Human Volunteers Approved 07/02/2012 No Approved 02/04/2012 Yes Approved 28/12/2011 Yes Date No Date Specified Condition The trial participants are those attending gynecological OPD and need not have any particular condition, they can be healthy as well. Type Details Age From Age To Gender Year(s) Year(s) Female Inclusion Criteria Details 1. Sexually active (at least for last one year) females, years of age, with at least one daughter of age between 9-18 years (both inclusive) 2. Women who have normal menstrual cycles or no bleeding after intercourse, OR Women who have abnormal bleeding or bleeding after intercourse 3. Able and willing to attend the counselling of cervical cancer 4. Able to fill the questionnaires used in this study 5. Able to give a written informed consent Exclusion Criteria Details 1. Pregnant Females 2. Females who are already vaccinated for HPV infection 3. Females whose daughter(s) aged 9-18 years are already vaccinated for HPV infection 4. Use of intra-vaginal medication within 24 hours prior to enrolment. page 4 / 9

5 Method of Generating Random Sequence Method of Concealment Blinding/Masking 5. Actively menstruating females Primary Outcome Outcome Timepoints Analysis of willingness for daughter s HPV vaccination based on results of mother s screening for HPV infection 12 months Secondary Outcome Outcome Timepoints 1. Analysis of willingness for self HPV screening after counselling for cervical cancer and its prevention 2. Analysis of willingness for self HPV vaccination after counselling for cervical cancer and its prevention 3. Analysis of willingness for daughter s vaccination after counselling for cervical cancer and its prevention 4. Analysis of willingness for self HPV vaccination based on results of self HPV screening 12 months Target Sample Size Phase of Trial Phase 4 Date of First Enrollment (India) Date of First Enrollment (Global) Estimated Duration of Trial 5. Comparison of willingness for daughter s HPV vaccination after mother s screening for HPV according to subject s socio-economic class 6. Comparison of willingness of daughter s vaccination pre HPV screening versus post HPV screening 7. Comparison of willingness for self HPV vaccination after screening for HPV according to subject s socio-economic class 8. Analysis of the HPV genotypes present in the subject. 9. Analysis of barriers for self HPV vaccination 10. Analysis of barriers for daughter s HPV vaccination Total Sample Size=564 Sample Size from India=564 15/01/2012 No Date Specified Years=1 Months=6 12 months 12 months page 5 / 9

6 Recruitment Status of Trial (Global) Recruitment Status of Trial (India) Publication Details Brief Summary Days=0 Completed Although no screening program can be 100% effective but the aim of cervical cancer screening is to detect abnormalities of the cervix at the pre-invasive stage of the disease. This is usually termed pre-cancer and means an abnormality of the outer skin or epithelial layer of the cervix, which, if untreated may lead to invasive cancer. Cells shed from the pre-cancer area may be used to detect the cervical abnormalities. No country has succeeded in conducting a program which may result in elimination of cervical cancer as a cause of death. The high mortality rate due to cervical cancer is primarily due to late diagnosis of the disease in III or IV stage, when the curable treatment is impossible. The late diagnosis of cervical cancer is due to low awareness among women about importance of regular gynaecological examinations. An education program may be conducted to increase the women s awareness about the importance of regular gynaecological observations for early stage diagnosis and curative treatment of cervical cancer. The risk of cervical cancer can also be reduced with the vaccination of females who are in the sexually active age or who are prone to infection of HPV. The present study aims at assessing the behavioural change in women towards the vaccination for cervical cancer to self and to her daughter, after providing them the necessary education about cervical cancer and sharing the results of their current status of HPV infection. Primary Objective: Analysis of willingness for daughter s HPV vaccination based on results of mother s screening for HPV infection.. Secondary Objective: 1. Analysis of willingness for self HPV screening after counselling for cervical cancer and its prevention 2. Analysis of willingness for self HPV vaccination after counselling for cervical page 6 / 9

7 cancer and its prevention 3. Analysis of willingness for daughter s vaccination after counselling for cervical cancer and its prevention 4. Analysis of willingness for self HPV vaccination based on results of self HPV screening 5. Comparison of willingness for daughter s HPV vaccination after mother s screening for HPV according to subject s socio-economic class 6. Comparison of willingness for daughter s vaccination pre HPV screening versus post HPV screening 7. Comparison of willingness for self HPV vaccination after screening for HPV according to subject s socio-economic class 8. Analysis of the HPV genotypes present in the subject 9. Analysis of barriers for self HPV vaccination 10. Analysis of barriers for daughter s HPV vaccination Study Design: This is a multicenter, prospective study which will be carried out over a period of 18 months- 2 years. page 7 / 9

8 Sample Size: All enrolled subjects will be counselled using standard education material. Subject enrolment will end once a HPV screening for a total of 564 subjects will be completed. The study will be carried out at 12 centers across India. Study Procedure: The study does not aim to intervene with the procedures normally associated with diagnosing and treating subjects with cervical cancer/hpv infection. However, it aims to assess the willingness in Indian female population for HPV screening, daughter s vaccination, and self-vaccination for HPV after awareness about cervical cancer and awareness about self HPV infection status. Approximately 12 investigational sites known to diagnose and treat gynaecological problems in India will be invited to participate in the study. Data will be obtained from gynaecologists. The study will involve the following steps 1. The subjects will be given the information about study and will be asked to sign the informed consent form (appendix I). 2. The subjects will then undergo the counselling session for cervical cancer and its prevention using the standard education material. 3. After the session the subject will be asked to mark her responses in the Behavioural Questionnaire - 1 (Appendix II). The questionnaire will be about the willingness of subject for HPV screening, daughter s HPV vaccination, and self HPV vaccination. page 8 / 9

9 Powered by TCPDF ( PDF of Trial 4. The subjects will also be asked to mark their responses in the Kuppuswamy s Socioeconomic Status Scale Questionnaire (Appendix IV), which will be used to evaluate the socioeconomic status of the subject. 5. The subjects will be asked if they are willing to undergo HPV screening test to check for infection with HPV. 6. The subjects willing to undergo the HPV screening test will then be asked to provide cervical swab samples for HPV DNA detection. 7. The subject will then be asked to come to the site on the 10th day (+2days) to collect the results of the test. 8. The samples found positive for HPV infection will be tested to find out which genotype of HPV is present. 9. The subjects not willing to undergo HPV screening test will not be required to come on the site for the 2nd visit. No further data will be collected for such patients. 10. At the second visit, after the results are shared with subject, she will be asked to mark her responses in the Behavioural Questionnaire 2 (Appendix III). The questionnaire will be about the willingness of subject for daughter s HPV vaccination, and self HPV vaccination and particular reasons for not opting for vaccination (barriers for vaccination). 11. The data will be recorded in the CRF. page 9 / 9