| CTRI Number |
CTRI/2026/02/104532 [Registered on: 23/02/2026] Trial Registered Prospectively |
| Last Modified On: |
23/02/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
A Study to Understand Outcomes in High-Risk Endometrial Cancer Patients in India Based on Molecular Testing. |
|
Scientific Title of Study
|
Prognostic Impact of Molecular Classification in High-Risk Endometrial
Cancer - A Retrospective Study in an Indian Cohort. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Anbarasan Sekar |
| Designation |
Associate Professor, Department of Medical Oncology |
| Affiliation |
Advanced Centre for Treatment, Research and Education in Cancer |
| Address |
Room Number 210 Pay Master Shodhika Building Advanced Centre for Treatment Research and Education in Cancer Sector 22 Utsav Chowk CISF Rd Owe Camp Kharghar Navi Mumbai Maharashtra 410210
Raigarh
MAHARASHTRA
410210
India |
| Phone |
8124227205 |
| Fax |
|
| Email |
anbarasan157@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anbarasan Sekar |
| Designation |
Associate Professor, Department of Medical Oncology |
| Affiliation |
Advanced Centre for Treatment, Research and Education in Cancer |
| Address |
Room Number 210 Pay Master Shodhika Building Advanced Centre for Treatment Research and Education in Cancer Sector 22 Utsav Chowk CISF Rd Owe Camp Kharghar Navi Mumbai Maharashtra 410210
Raigarh
MAHARASHTRA
410210
India |
| Phone |
8124227205 |
| Fax |
|
| Email |
anbarasan157@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Anbarasan Sekar |
| Designation |
Associate Professor, Department of Medical Oncology |
| Affiliation |
Advanced Centre for Treatment, Research and Education in Cancer |
| Address |
Room Number 210 Pay Master Shodhika Building Advanced Centre for Treatment Research and Education in Cancer Sector 22 Utsav Chowk CISF Rd Owe Camp Kharghar Navi Mumbai Maharashtra 410210
Raigarh
MAHARASHTRA
410210
India |
| Phone |
8124227205 |
| Fax |
|
| Email |
anbarasan157@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Investigator Initiated Trial |
| Address |
NIL |
| Type of Sponsor |
Other [We are applying for intramural funds] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| ISMPO Indian Society of Medical and Paediatric Oncology |
Room No. 22, Floor-2, Plot-148, Rangwala Building, Saint Paul Street, Near Hindmata Talkies, Dadar (E), Mumbai-400014 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Anbarasan Sekar |
Advanced Centre for Treatment, Research and Education in Cancer (ACTREC |
OPD Number 213 Shanti Sadan OPD Building Advanced Centre for Treatment Research and Education in Cancer Sector 22 Utsav Chowk CISF Rd Owe Camp Kharghar Navi Mumbai Maharashtra 410210
Raigarh
MAHARASHTRA |
08124227205
anbarasan157@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee III |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C509||Malignant neoplasm of breast of unspecified site, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Female |
| Details |
1. Histologically confirmed high-risk endometrial cancer
2. FIGO stage IB grade 3 and above
3. Stage II–III endometrioid carcinoma
4. Any stage serous or clear-cell carcinoma
5. Completion of primary surgery and adjuvant therapy
6. Availability of FFPE tissue |
|
| ExclusionCriteria |
| Details |
1. Low-risk endometrial cancer or missing critical clinical/tissue data
2. Recurrent/metastatic disease at initial presentation
3. Lost to follow-up within six months post-treatment |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Assess the impact of molecular classification (POLEmut, MMRd, p53abn,
NSMP) on clinical outcomes, including progression-free survival (PFS)
and overall survival (OS), in Indian patients with high-risk endometrial
cancer. |
24 Months (2 Year) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
- To describe the distribution of molecular subtypes in high-risk EC
patients in India.
- To correlate molecular classification with clinicopathologic variables
such as age, stage, histology, and lymphovascular space invasion
(LVSI).
- To assess patterns of recurrence (local vs. distant) by molecular
subgroup. |
24 Months (2 Year) |
|
|
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)
|
16/03/2026 |
| 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="2"
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
|
Project Title: Prognostic Impact of Molecular Classification
in High-Risk Endometrial Cancer - A Retrospective Study in
an Indian Cohort.
Endometrial cancer is a common cancer in women. While most
cases are detected early and have good outcomes, some are high-risk
and can behave aggressively. Recent studies have shown that
molecular features of the tumor (such as POLE mutation, MMR
deficiency, and p53 abnormality) can predict prognosis better than
traditional methods.
This retrospective study will analyze data of about 250 patients with
high-risk endometrial cancer treated at Tata Memorial Centre
between September 2019 and September 2025. Archived FFPE
(Formalin-Fixed, Paraffin-Embedded tissue) tumor samples will be
tested for molecular classification, and outcomes will be correlated
with these subtypes.
No new samples will be collected, and all data will be anonymized.
There are no risks to participants, and findings may contribute to
improving cancer care in the future. |