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CTRI Number  CTRI/2025/05/086463 [Registered on: 06/05/2025] Trial Registered Prospectively
Last Modified On: 06/05/2025
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Multicentric Registry 
Study Design  Other 
Public Title of Study   Effect of Molecular, Pathological and Clinical features in choosing best treatment for Endometrial Cancer: A registry from multiple Asian institutes 
Scientific Title of Study   Impact of Molecular Pathological And Clinical features for adjuvant Treatment selection in Endometrial cancer: Multicentric Asian Registry (IMPACT-Endo-Asia) 
Trial Acronym  IMPACT-Endo-Asia 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Supriya Chopra  
Designation  Prof. Radiation Oncology  
Affiliation  ACTREC Tata Memorial Centre 
Address  PS-246 Paymaster Shodhika, Department of Radiation Oncology, Advanced Centre for Treatment, Research and Education in Cancer (ACTREC) Tata Memorial Centre, Sector 22,Kharghar, Navi Mumbai-410210

Raigarh
MAHARASHTRA
410210
India 
Phone  9930958309  
Fax    
Email  supriyasastri@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Supriya Chopra  
Designation  Prof. Radiation Oncology  
Affiliation  ACTREC Tata Memorial Centre 
Address  PS-246 Paymaster Shodhika, Department of Radiation Oncology, Advanced Centre for Treatment, Research and Education in Cancer (ACTREC) Tata Memorial Centre, Sector 22,Kharghar, Navi Mumbai-410210

Raigarh
MAHARASHTRA
410210
India 
Phone  9930958309  
Fax    
Email  supriyasastri@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Supriya Chopra  
Designation  Prof. Radiation Oncology  
Affiliation  ACTREC Tata Memorial Centre 
Address  PS-246 Paymaster Shodhika, Department of Radiation Oncology, Advanced Centre for Treatment, Research and Education in Cancer (ACTREC) Tata Memorial Centre, Sector 22,Kharghar, Navi Mumbai-410210

Raigarh
MAHARASHTRA
410210
India 
Phone  9930958309  
Fax    
Email  supriyasastri@gmail.com  
 
Source of Monetary or Material Support  
Department of Radiation Oncology, Tata Memorial Hospital, Parel, Mumbai and ACTREC, Tata Memorial Centre, Kharghar,Navi Mumbai 
 
Primary Sponsor  
Name  None 
Address  Not applicable 
Type of Sponsor  Other [Not applicable] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India
Indonesia
Philippines
Thailand  
Sites of Study  
No of Sites = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Supriya Chopra  ACTREC, Tata Memorial Centre  Kharghar, Navi Mumbai
Raigarh
MAHARASHTRA 
9930958309

supriyasastri@gmail.com 
Dr Supriya Chopra  Tata Memorial Hospital  Parel, Mumbai
Mumbai
MAHARASHTRA 
9930958309

supriyasastri@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, Tata Memorial Hospital  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 
Intervention  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  90.00 Year(s)
Gender  Female 
Details  Patients who were diagnosed to have Endometrial Cancer and have access to standard histopathological reports and availability of treatment decisions.  
 
ExclusionCriteria 
Details  Patients with final histopathological diagnosis of any other gynecological malignancy other than Endometrial Cancer and its subtypes.  
 
Method of Generating Random Sequence    
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
The retrospective study and data analysis offer a promising opportunity to pave the way for a prospective study in the future, thereby providing an avenue to streamline the adjuvant treatment decisions for endometrial cancer patients. By adopting a standardized treatment approach, we can work towards improving patient outcomes and enhancing the quality of care.  3 years 
 
Secondary Outcome  
Outcome  TimePoints 
None   
 
Target Sample Size   Total Sample Size="300"
Sample Size from India="125" 
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)   02/06/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  02/06/2025 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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 treatment practices for endometrial cancer have significantly changed over the last two decades. Nowadays, in addition to standard pathology, additional tests are performed to understand  the behaviour of tumour so that personalized treatment can be advised for every patient. This approach ensures that patients with good cancer cell features receive minimum  essential radiotherapy or surgery treatment with fewer side effects, while those with poor cell features undergo more aggressive treatment to improve their chances of survival. However, this approach is not widely adopted in Asian countries. To address this, we are launching a project to gather data from various hospitals across Asia. The project aims to understand how different cancer cell factors impact treatment decisions and identify better ways to select additional treatment plans based on a patient’s cancer cell features. The project will gather data from around 300 patients who were evaluated or treated between January 2021 and December 2023. It will run for two years to improve our understanding and gain insights into the best ways to treat endometrial cancer.

 
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