| CTRI Number |
CTRI/2026/02/104648 [Registered on: 24/02/2026] Trial Registered Prospectively |
| Last Modified On: |
19/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Treating Endometrial Cancer with Precision: A New Era of Personalized Medicine |
|
Scientific Title of Study
|
Molecular profiling of Endometrial Cancer and its impact on designing personalized therapy |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Nutan Sahu |
| Designation |
Senior Resident , Gynaecologic Oncology |
| Affiliation |
AIIMS |
| Address |
Room no. 726, MCH, 7th floor, AIIMS
New Delhi
DELHI
110029
India |
| Phone |
07982123119 |
| Fax |
|
| Email |
nnutan709@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Seema Singhal |
| Designation |
Professor, Department of Obstetrics and Gyanecology |
| Affiliation |
AIIMS, New Delhi |
| Address |
Room no. 726, MCH, 7th floor, AIIMS, New Delhi- 110029, INDIA
New Delhi
DELHI
110029
India |
| Phone |
9818291001 |
| Fax |
|
| Email |
drseemasinghal@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Nutan Sahu |
| Designation |
Senior Resident , Gynaecologic Oncology |
| Affiliation |
AIIMS |
| Address |
Room no. 726, MCH, 7th floor, AIIMS
DELHI
110029
India |
| Phone |
07982123119 |
| Fax |
|
| Email |
nnutan709@gmail.com |
|
|
Source of Monetary or Material Support
|
| Gynae office, MCH Block, 7th floor, AIIMS, New Delhi
Pincode-110029
India |
|
|
Primary Sponsor
|
| Name |
none |
| Address |
NA |
| Type of Sponsor |
Other [NOT SPONSORED] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| NIL |
NIL |
| 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 Seema Singhal |
AIIMS, New Delhi, INDIA |
Room no 726, MCH BLOCK, Gynaecologic Oncology division of Department of obstetrics and Gynaecology, AIIMS, New Delhi- 110029, INDIA
New Delhi
DELHI |
9818291001
drseemasinghal@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| AIIMS Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C548||Malignant neoplasm of overlappingsites of corpus uteri, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Female |
| Details |
1.Women with histological diagnosis of ca
endometrium
2. All histologies including endometrioid
or high-risk histology (serous, clear cell,
carcinosarcoma and mixed histologies)
3. Planned surgical staging with SLN
mapping. |
|
| ExclusionCriteria |
| Details |
1.Prior chemotherapy or pelvic
radiotherapy.
2. Presence of synchronous malignancies
and Recurrent cases
3. Known hypersensitivity to dye
4. Uterine sarcoma |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. No of cases with POLE, MMRd, p53 and NSMP profile
2. Number of patients with macro metastasis, micro metastasis and iTC in mapped sentinel
nodes
3. Correlation of SLN metastasis among different molecular subtypes.
4. No of patients needing each modality of adjuvant therapy using conventional HPE
5. No of patients needing each modality of adjuvant therapy using molecular profiling
|
4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
10/03/2026 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
10/03/2026 |
| 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
|
Endometrial cancer is one of the most prevalent gynecological malignancies, with a significant
increase in both incidence and mortality over the past decade. The estimated number of new
cases of endometrial cancer in India in 2022 was 17,420 with an estimated deaths of about 6845
and ranks 3rd in number among female genital tract malignancies. This upward trajectory is
largely attributed to increased life expectancy and the rising prevalence of risk factors such as
obesity, which has become a major contributor to the growing incidence of the disease. The adoption of sentinel lymph node (SLN) mapping has emerged as a promising technique to
overcome the issues associated with traditional lymphadenectomy, providing reliable data on
nodal involvement. Furthermore, the use of ultra-staging in SLN mapping allows for the
detection of low-volume disease, including isolated tumor cells and micro-metastases, which
are often missed by conventional histopathological methods. This advancement has
significantly improved the accuracy of staging and treatment planning.
One of the most impactful innovations in endometrial cancer management has been the
integration of molecular and genomic profiling. The landmark data from The Cancer Genome
Atlas (TCGA) published in 2013, followed by updates from the European Society for Medical
Oncology (ESMO), European Society of Gynaecological Oncology (ESGO), and the
International Federation of Gynecology and Obstetrics (FIGO), have led to a better
understanding of the molecular heterogeneity of this disease. Our hypothesis is that there will be differences in sentinel lymph node involvement rates and adjuvant therapy pathways if molecular classification is integrated in conventional management for patients with endometrial cancer. This might provide evidence to escalate or de-escalate therapeutic
decisions and personalized management. However, there is currently no prospective evidence supporting the use of molecular
classification to guide surgical or adjuvant treatment decisions. This prospective study aims to
evaluate the predictive value of molecular features over the conventional histopathological
prognostic factors for planning adjuvant therapy and for identifying the risk of sentinel nodal
metastases in endometrial cancer. |