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CTRI Number  CTRI/2025/08/092561 [Registered on: 06/08/2025] Trial Registered Prospectively
Last Modified On: 05/08/2025
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Ovarian Cancer Real World Evidence study to evaluate the baseline demographics and clinicopathological characteristics of patients initiated on Olaparib. 
Scientific Title of Study   An ambispective crosssectional multi-center non interventional cohort study to evaluate the clinical profile of ovarian cancer patients initiated on Olaparib and correlation of mutation status (BRCA & HRD) with clinicopathologic characteristics 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
CP/06/25, Version 1.0, Dated 14.06.2025  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Narayanan Kutty Warrier 
Designation  Principal Investigator 
Affiliation  MVR Cancer Center and Research Institute 
Address  Room number 3 ground floor department of Oncology MVR Cancer Center and Research Institute CP 13/516 B C Vellalasseri Poolacode Kozhikode 673601 Kerala India

Kozhikode
KERALA
673601
India 
Phone  9495617585  
Fax    
Email  drnkwarrier@mvrccri.co  
 
Details of Contact Person
Scientific Query  
Name  Dr Sucheta Mehta 
Designation  Head Medical Affairs Super-Specialties 
Affiliation  Cipla Limited 
Address  A Wing First Floor Cipla Limited 289 Bellasis opposite Sahil Hotel Mumbai Maharashtra 400008

Mumbai
MAHARASHTRA
400008
India 
Phone  9820305797  
Fax    
Email  dr.sucheta@cipla.com  
 
Details of Contact Person
Public Query  
Name  Dr Devang Sarvaiya 
Designation  Team Lead Medical Affairs Oncology 
Affiliation  Cipla Limited 
Address  Wing C Fourth Floor Cipla Limited 289 Bellasis opposite Sahil Hotel Mumbai Maharashtra 400008

Mumbai
MAHARASHTRA
400008
India 
Phone  9773012461  
Fax    
Email  devang.sarvaiya@cipla.com  
 
Source of Monetary or Material Support  
Cipla Ltd Peninsula Business Park Ganpatrao Kadam Marg Lower Parel Mumbai 400 013 India 
 
Primary Sponsor  
Name  Cipla Ltd 
Address  Cipla House Peninsula Business Park Ganpatrao Kadam Marg Lower Parel Mumbai 400 013 India 
Type of Sponsor  Pharmaceutical industry-Indian 
 
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 Narayanan Kutty Warrier  MVR Cancer Center Research Institute  MVR Cancer Center Research Institute CP 13 516 B C Vellalasseri Poolacode Kozhikode 673601 Kerala India
Kozhikode
KERALA 		 9495617585

drnkwarrier@mvrccri.co 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ethicare Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C569||Malignant neoplasm of unspecifiedovary,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Female 
Details  Female patient of more than or equal to 18 years of age
Previously treated or newly diagnosed ovarian primary peritoneal or fallopian tube cancer patients prescribed on Olaparib naïve or initiated equal to or less than 3 months
Mutation status BRCA positive or HRD plus BRCA negative or HRD positive
 
 
ExclusionCriteria 
Details  Failed to provide written informed consent
Any medical condition that in the opinion of the investigator would interfere with safe completion of the study, or were participating in any other clinical 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Baseline demography including molecular characteristics age gender comorbidities primary treatment family history BRCA1 BRCA2 mutation and HRD status  Baseline  
 
Secondary Outcome  
Outcome  TimePoints 
Assess the co-relation of BRCA and HRD status
Lifestyle medical history and symptoms
Family history
Histopathologic type of OC
Previous lines of treatment 		 Baseline 
 
Target Sample Size   Total Sample Size="250"
Sample Size from India="250" 
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)   29/08/2025 
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  

Ovarian cancer is a leading cause of cancer-related mortality among women. Olaparib, a PARP inhibitor, is indicated in the treatment of Ovarian cancer patients with specific genetic mutations – BRCA & HRD. Comprehensive data from multiple centers across India on the real-world usage of Olaparib in eligible ovarian cancer patients, remains limited for a larger subset of patients. Additionally, demographic and clinicopathological data on ovarian cancer patients receiving Olaparib is not widely available in India, necessitating this study to bridge the data gap. By addressing these deficiencies, this study aims to evaluate the clinical profiles of OC patients prescribed with Olaparib, focusing on their baseline demographics including molecular characteristics, response to previous treatments, and to assess correlation of BRCA/HRD with clinicopathologic characteristics.

 
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