| 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
|
|
|
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
|
|
|
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
|
|
|
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. |