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CTRI Number  CTRI/2018/08/015338 [Registered on: 14/08/2018] Trial Registered Prospectively
Last Modified On: 01/04/2022
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   A Non-interventional, multicentre study to see prevalence of BRCA1 and BRCA2 mutation among ovarian, primary peritoneal and fallopian tube cancer patients in India 
Scientific Title of Study   A Non-interventional, multicentre study to assess prevalence of BRCA1 and BRCA2 mutation among ovarian, primary peritoneal and fallopian tube cancer patients in India ( BRCA Study) 
Trial Acronym  BRCA Study 
Secondary IDs if Any  
Secondary ID  Identifier 
D0818R00001 version 1.0 , 08 November 2017   Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Sudeep Gupta 
Designation  Professor of Medical Oncology 
Affiliation  Tata Memorial Hospital 
Address  Room No. 1109, 11th floor, Homi Bhabha Block, Tata Memorial Hospital, Parel, Mumbai-400012

Mumbai
MAHARASHTRA
400012
India 
Phone    
Fax    
Email  sudeepgupta04@yahoo.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Rohit Kodagali 
Designation  Study Physician  
Affiliation  AstraZeneca Pharma India Ltd 
Address  Block N1 12th Floor Manyata Embassy Business Park Rachenahalli Outer Ring Road Bangalore KARNATAKA 560045 India

Bangalore
KARNATAKA
560045
India 
Phone  9820301179  
Fax    
Email  rohit.kodagali@astrazeneca.com  
 
Details of Contact Person
Public Query  
Name  Amit Kumar 
Designation  Study Delivary Lead 
Affiliation  AstraZeneca Pharma India Ltd 
Address  Block N1 12th Floor Manyata Embassy Business Park Rachenahalli Outer Ring Road Bangalore KARNATAKA 560045 India

Bangalore
KARNATAKA
560045
India 
Phone  9972365541  
Fax    
Email  amit.kumarak@astrazeneca.com  
 
Source of Monetary or Material Support  
AstraZeneca Pharma India Limited. Block N1, 12th Floor, Manyata Embassy Business Park Rachenahalli, Outer Ring Road, Bangalore-560045  
 
Primary Sponsor  
Name  AstraZeneca Pharma India Ltd 
Address  AstraZeneca Pharma India Limited Block N1, 12th Floor, Manyata Embassy Business Park Rachenahalli, Outer Ring Road, Bangalore-560045 
Type of Sponsor  Pharmaceutical industry-Global 
 
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 Sudeep Gupta  Tata Memorial Hospital  Room No.1109,11th floor, Homi Bhabha Block, Tata Memorial Centre Parel, Mumbai
Mumbai
MAHARASHTRA 		 02224177201

sudeepgupta04@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institute Ethics Commitee Tata Memorial Hospital   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  ovarian, primary peritoneal and fallopian tube cancer patients,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Female 
Details  1. Patients who provide written informed consent
2. Female ≥ 18 years of age
3. Previously or newly diagnosed ovarian, primary peritoneal, or fallopian tube cancer patients. 
 
ExclusionCriteria 
Details  1. Patient with any medical condition that, in the opinion of the investigator, would interfere with safe completion of the study
2. Patient participating in any other clinical study/ trial. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
The proportion of previously and newly diagnosed ovarian, primary peritoneal or fallopian tube cancer patients with BRCA1 or BRCA2 mutations positive status.  One day 
 
Secondary Outcome  
Outcome  TimePoints 
1. Level of association between histopathological type and BRCA 1/BRCA 2 mutation positive status  One day 
2. To assess the association of BRCA1/BRCA2 mutation positive status and family history of breast and/or ovarian cancer and any cancer.
• Patients having Family history of Ovarian cancer in first degree relative
• Patients having family history of both Ovarian and breast cancer in first degree relative,
• Patients having family history of breast cancer in first degree relative,
• Patients having family history of Ovarian/other cancer before 45 years of age. 		 NA 
3. To determine the BRCA1/BRCA2 mutation distribution in Indian population.  NA 
 
Target Sample Size   Total Sample Size="240"
Sample Size from India="240" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" 
Phase of Trial   N/A 
Date of First Enrollment (India)   01/10/2018 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   NA 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary   This is a non-interventional, cross-sectional, multicentre, prospective, observational study to be conducted at 15 sites from different geographical regions across India. The study targets to enrol 240 patients with nearly 16 patients per site over 6 months. The study will enrol females with diagnosis of ovarian, primary peritoneal, or fallopian tube cancer. No study medication will be prescribed or administered as a part of study procedure. 
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