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CTRI Number  CTRI/2024/02/062918 [Registered on: 20/02/2024] Trial Registered Prospectively
Last Modified On: 15/02/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Role of Bcl-2 and Ki67 in endometrial lesions 
Scientific Title of Study   Immunohistochemical expression of Bcl-2 and Ki-67 in non-neoplastic and neoplastic endometrial lesions- A cross sectional study 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Pragya chitravanshi  
Designation  Junior resident  
Affiliation  Rohilkhand Medical College and Hospital 
Address  Room no. 1162 Department of Pathology Rohilkhand medical college and hospital pilibhit bypass road bareilly

Bareilly
UTTAR PRADESH
243006
India 
Phone  8948946349  
Fax    
Email  chitravanshipragya@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Anjana arya  
Designation  Professor 
Affiliation  Rohilkhand Medical College and Hospital  
Address  Department of pathology room no 1164 Rohilkhand medical college and hospital

Bareilly
UTTAR PRADESH
243006
India 
Phone  9412125824  
Fax    
Email  anjanaarya.singh15@gmail.com  
 
Details of Contact Person
Public Query  
Name  Pragya chitravanshi  
Designation  Junior resident  
Affiliation  Rohilkhand medical college and hospital 
Address  Room no. 1162 Department of Pathology Rohilkhand medical college and hospital pilibhit bypass road bareilly

Bareilly
UTTAR PRADESH
243006
India 
Phone  8948946349  
Fax    
Email  chitravanshipragya@gmail.com  
 
Source of Monetary or Material Support  
Rohilkhand Medical College and Hospital Pilibhit Bypass road Bareilly Uttar Pradesh 243006 
 
Primary Sponsor  
Name  Pragya chitravanshi  
Address  Rohilkhand Medical College and Hospital pilibhit bypass road bareilly  
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Pragya chitravanshi   Rohilkhand Medical College and Hospital  Room no 1162 Department of Pathology Rohilkhand Medical college and Hospital
Bareilly
UTTAR PRADESH 		 8948946349

chitravanshipragya@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, RMCH, Bareilly, U.P  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C541||Malignant neoplasm of endometrium,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  90.00 Year(s)
Gender  Female 
Details  All histopathologically confirmed cases of non neoplastic and neoplastic endometrial lesions.  
 
ExclusionCriteria 
Details  Patients who are on hormonal therapy
Biopsies diagnosed as the product of conception
Biopsies that are unsatisfactory  
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To classify non neoplastic and neoplastic endometrial lesions on the basis of histomorphology.
To evaluate Bcl-2 and Ki-67 expression in non-neoplastic and neoplastic endometrial lesions.
To correlate Bcl-2 with Ki-67 expression in these lesions  		 Monthly  
 
Secondary Outcome  
Outcome  TimePoints 
To classify non neoplastic & neoplastic endometrial lesions on the basis of histomorphology.

To evaluate Bcl-2 & Ki-67 expression in non-neoplastic & neoplastic endometrial lesions.

To correlate Bcl-2 with Ki-67 expression in these lesions 		 4 weeks 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   25/02/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  
The study will be conducted in the Department of Pathology Rohilkhand Medical
College and Hospital, Bareilly after taking approval from Institutional Ethics
Committee, and consent from the patient and will include all endometrial biopsies and
hysterectomy specimens in the department during the study period.
The received specimens will be subjected to gross and microscopic examination as per
standard protocol.
Paraffin embedded tissues (4-5 microns) will be cut and stained by Haematoxylin and
Eosin stain.
Immunohistochemistry will be carried out using Bcl-2 and Ki-67 as primary antibodies
and High Reactive Polymer as a secondary kit.
Microwave antigen retrieval will be carried out in pH 9 TrisEDTA buffer. Using DAB
as the chromogen, staining.
Observations will be made on Immunohistochemistry stained slides and documented.
Prepared slides will be viewed under an optical microscope x400 magnification, for
positive or negative immunostaining.
Biopsies which shows positive for Bcl-2 and Ki-67 expressions will be included.
Calculations will be made regarding staining percentage and intensity.
The positive number of cells for Bcl-2 expressions will count in 100 epithelial cells and
repeated in 10 HPFs. [7]
Positive epithelial cells will be graded on the basis of intensity. [7]
910
o Grade 0 – Absent
o Grade 1 –Mild
o Grade 2 – Moderate
o Grade 3 – Strong
o Grade 4 – Very strong
Positive control: Placental tissue will be used as a positive control for Bcl-2 whose
staining is always grade 4.[7]
The positive number of cells for Ki-67 expressions will count in 100 epithelial cells and
repeated in 10 HPFs and then positive cells for Ki-67 expressions will be calculated
using the percentage of 1000. these cells will be graded on the basis of their positivity
as follows.[7]
o <5% - Grade 0
o 6-25% - Grade 1
o 26-50% - Grade 2
o 51- 75% - Grade 3
o 76-100% - Grade 4
Positive control: Tonsil will be taken as a control for Ki-67 expression
 
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