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1 Clinical Trial Details (PDF Generation Date :- Sun, 25 Nov :22:24 GMT) CTRI Number Last Modified On 06/07/2013 Post Graduate Thesis Type of Trial Type of Study Study Design Public Title of Study Scientific Title of Study CTRI/2013/07/ [Registered on: 19/07/2013] - Trial Registered Retrospectively Yes Observational Cohort Study Other assessment of prostate gland histology correlative study of gleason score with morphological criteria in adenocarcinoma prostate 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 Name Designation Affiliation Address NIL Details of Principal Investigator Dr Abhishek Kumar Phone Fax Name Designation Affiliation Address post graduate pathology(dcp) father muller medical college FATHER MULLER MEDICAL COLLEGE HOSPITAL, FATHER MULLER ROAD, KANKANADY, MANGALORE Dakshina Kannada KARNATAKA India abhi_doc711@ymail.com Details Contact Person (Scientific Query) Dr Nisha J Marla Associate Professor Phone Fax Name Designation Affiliation Address father muller medical college DEPT OF PATHOLOGY FATHER MULLER MEDICAL COLLEGE HOSPITAL, FATHER MULLER ROAD, KANKANADY, MANGALORE Dakshina Kannada KARNATAKA India nishajmarla@gmail.com Details Contact Person (Public Query) Dr Abhishek Kumar post graduate pathology(dcp) father muller medical college FATHER MULLER MEDICAL COLLEGE HOSPITAL, FATHER MULLER ROAD, KANKANADY, MANGALORE Dakshina Kannada KARNATAKA India page 1 / 14

2 Source of Monetary or Material Support Primary Sponsor Details of Secondary Sponsor Countries of Recruitment Sites of Study Details of Ethics Committee Regulatory Clearance Status from DCGI Health Condition / Problems Studied Intervention / Comparator Agent Inclusion Criteria Exclusion Criteria Method of Generating Random Sequence Method of Concealment Blinding/Masking Phone Fax > father muller medical college Name Address Type of Sponsor Name NIL List of Countries India Name of Principal Investigator Dr Abhishek Kumar abhi_doc711@ymail.com Source of Monetary or Material Support Primary Sponsor Details father muller medical college FATHER MULLER MEDICAL COLLEGE HOSPITAL, FATHER MULLER ROAD, KANKANADY, MANGALORE Research institution and hospital Address NIL Name of Site Site Address Phone/Fax/ father muller medical college Dept of Pathology father muller medical college kankanady mangalore Dakshina Kannada KARNATAKA abhi_doc711@ymail.co m Name of Committee Approval Status Date of Approval Is Independent Ethics Committee? father muller institutional ethics committee Status Not Applicable Health Type Patients Approved 19/10/2012 No Date No Date Specified Condition adenocarcinoma prostate Type Name Details Age From Age To Gender Details Details Not Applicable Not Applicable Not Applicable Year(s) Year(s) Male Inclusion Criteria cases diagnosed positive for adenocarcinoma prostate Exclusion Criteria cases of nodular hyperplasia of prostate, prostatic intraepithelial lesion, prostatitis Primary Outcome Outcome Timepoints a correlative study between positive adenocarcinoma cases with distinct different 2 years page 2 / 14

3 morphological criteria Secondary Outcome Outcome Timepoints Target Sample Size Phase of Trial Date of First Enrollment (India) Date of First Enrollment (Global) Estimated Duration of Trial Recruitment Status of Trial (Global) Recruitment Status of Trial (India) Publication Details Brief Summary to grade biopsies Total Sample Size=69 Sample Size from India=69 N/A 01/01/2011 No Date Specified Years=2 Months=0 Days=0 Not Applicable Completed 2 years SYNOPSIS Rajiv Gandhi University of Health Sciences, Karnataka, Bangalore. CORRELATIVE STUDY OF GLEASON SCORE WITH MORPHOLOGICAL CRITERIA IN DIAGNOSIS OF ADENOCARCINOMA PROSTATE Name of the candidate : Dr. Abhishek Kumar page 3 / 14

4 Guide : Dr. Nisha J. Marla Course and Subject : Pathology Department of Pathology, Father Muller Medical College, Kankanady, Mangalore May 2012 RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES BANGALORE, KARNATAKA 1. Name of the candidate and address (in block letters) DR. ABHISHEK KUMAR P.G. RESIDENT page 4 / 14

5 FATHER MULLER MEDICAL COLLEGE KANKANADY, MANGALORE Name of the institution FATHER MULLER MEDICAL COLLEGE KANKANADY, MANGALORE Course of study and subject D.C.P. (PATHOLOGY) 4. Date of admission to the course Title of the topic: CORRELATIVE STUDY OF GLEASON SCORE WITH MORPHOLOGICAL CRITERIA IN DIAGNOSIS OF ADENOCARCINOMA PROSTATE BRIEF RESUME OF THE INTENDED WORK: 6.1 NEED FOR THE STUDY The Gleason histological grade for adenocarcinoma prostate is one of the most significant predictors of its biologic behavior. It has an page 5 / 14

6 important role in determining patient s treatment and prognosis. Various studies 6. have firmly established that it serves as a vital pathologic predictor for disease outcome. In 2003, recognizing the importance of the Gleason grading system, the World Health Organization (WHO) endorsed Gleason grading as the standard pattern for reporting adenocarcinoma prostate. Since then the Gleason grading system has continued to play a critical role in the management, treatment and stratification of patients with prostate cancer. The knowledge and expertise in grading of adenocarcinoma prostate is of utmost significance to a pathologist. 6.2 Review of literature Prostate cancer contributes significantly to the overall cancer burden, being the page 6 / 14

7 most frequent malignant neoplasia in men. The high number of cases can be attributed to the fact that life expectancy has risen significantly over past few decades. An additional factor is the Western lifestyle, characterized by a high caloric diet and lack of physical exercise. Epidemiological data indicates that black people are most susceptible, followed by white people, while Asians have the lowest risk. But with more number of people following western lifestyle prostate cancer is on the rise in Asian countries too. An accurate diagnosis in prostate cancer depends on clinico-pathological correlation. While, the extent to which prostate cancer mortality can be reduced by PSA screening, is currently being evaluated, PSA has more of prognostic value. Singly it is not a sensitive tool but combined with DRE its sensitivity and specificity is higher. The final diagnosis rests on histopathological examination and Gleason grading plays key role in diagnosis of prostate cancer. page 7 / 14

8 Morphological criteria which help in differentiating malignancy from benign conditions are Ø nuclear changes Ø intraluminal contents Ø perineural invasion Ø malignant invasion in adipose tissue Ø cytoplasmic features Ø retraction glands Ø collagenous micronodules. These criteria though significant are not seen in all variants of carcinoma prostate hence have not been used earlier. An attempt thus is made hereby to study these criteria in cases of adenocarcinoma prostate. The Gleason grading system defines five histological patterns or grades with decreasing differentiation. Normal prostate epithelial cells are arranged around a page 8 / 14

9 lumen. In patterns 1 to 3, there is retained epithelial polarity with luminal differentiation in virtually all glands. In pattern 4, there is partial loss of normal polarity and in pattern 5, there is an almost total loss of polarity with only occasional luminal differentiation. Prostate cancer has a pronounced morphological heterogeneity and usually more than one histological pattern is present. The primary and secondary pattern, i.e. the most prevalent and the second most prevalent pattern are added to obtain a Gleason score or sum. It is recommended that the primary and secondary pattern as well as the score be reported, e.g. Gleason score 3+4=7. If the tumour only has one pattern, Gleason score is obtained by doubling that pattern, e.g. Gleason score 3+3=6. Gleason scores 2 and 3 are only exceptionally assigned, because Gleason pattern 1 is unusual. Gleason score 4 is also relatively uncommon because pattern 2 is usually mixed with some pattern 3 resulting in a Gleason score 5. Gleason score 2-4 may be seen in TURP material sampled from the transitional zone. In needle biopsy material, it has been proposed that a Gleason score of 2-4 should not be page 9 / 14

10 assigned. Gleason scores 6 and 7 are the most common scores and include the majority of tumours in most studies. 6.3 Objective of the study: a) To study morphology in all cases of carcinoma prostate. b) To grade biopsies according to Gleason score. c) To compare morphological criteria and Gleason score to know sensitivity evaluation. 7. MATERIALS AND METHODS 7.1 Source of data: Prostate specimens collected retrospectively and prospectively at Father Muller Medical College Hospital, department of Pathology will be included in this study. 7.2 Sample size: 50 cases. Design of the study: Correlative study. Duration of the study: January 1, 2011 December 31, 2012 (two years). page 10 / 14

11 7.3 METHOD OF COLLECTION OF DATA: Cases diagnosed from January 1, 2011 to December 31, 2012 will be studied. Retrospective and prospe collection of data will be done. All the cases positively diagnosed with cancer will be included in study. Morphological criteria and Gleason grades will be examined in each slide. A correlation betw morphological criteria and Gleason scores will be performed. Inclusion criteria All diagnosed cases of carcinoma prostate Exclusion Criteria Non neoplastic lesions Data Analysis Presence or absence of each morphological criteria against Gleason scores will be tabulated and infere shall be drawn. 7.4 Does the study require any investigations or interventions to be conducted on patients or othe humans or animals? page 11 / 14

12 YES 7.5 Has ethical clearance been obtained from your institution in case of 7.4? 8. LIST OF REFERENCES: 1. Epstein J.I, Algaba F, Allsbrook W.C Jnr, Bastacky S, De Marzo A.M, Rubin M.A et al. Tumours of prostate. In: Elbe J.N, Sauter G, Epstein J.I, Sesterheim I.A editors: WHO pathology and genetics of the urinary system and male genital organs. Lyon, IARC press; Velickovic L, Katic V, Tasic D.D, Dordevic B, Zivkovic V, Zivkovic S, Marjanovic G. Morphological criteria the diagnosis of prostatic adenocarcinoma in needle biopsy specimens. Arch Oncol 2004,march 23;12(supp1): Elizabeth J.M. Crystalloids in prostatic carcinoma - relationship with Bence-Jones crystals. Cancer 1976,July 30;39: Epstein J.I. Diagnosis of limited adenocarcinoma of the prostate. Histopathology 2012,60: Roe J.Y, Ayala A.G, Ordonez N.G, Cartwright J Jr, Mackay B. Intraluminal Crystalloids in Prostatic Adenocarcinoma Immunohistochemical, Electron Microscopic and X-Ray Microanalytical Studies. Can 1986,57: page 12 / 14

13 9. SIGNATURE OF THE CANDIDATE REMARKS FROM GUIDE NAME & DESIGNATION OF GUIDE DR. NISHA J. MARLA,MD ASSOCIATE PROFESSOR DEPARTMENT OF PATHOLOGY FR. MULLER MEDICAL COLLEGE MANGALORE SIGNATURE 11.3 HEAD OF DEPARTMENT DR. MUKTHA R. PAI, MD PROFESSOR AND HOD OF PATHOLOGY DEPARTMENT OF PATHOLOGY FR. MULLER MEDICAL COLLEGE KANKANADY, MANGALORE SIGNATURE REMARKS OF THE CHAIRMAN AND DEAN 12.2 SIGNATURE page 13 / 14

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