| CTRI Number |
CTRI/2024/11/077413 [Registered on: 27/11/2024] Trial Registered Prospectively |
| Last Modified On: |
22/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A study of molecular markers and risk stratification in Indian women with endometrial cancer. |
|
Scientific Title of Study
|
A study of molecular markers and risk stratification in Indian women with endometrial cancer: An Ambispective study. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Kavita Khoiwal |
| Designation |
Additional Professor |
| Affiliation |
AIIMS Rishikesh |
| Address |
Department of obstetrics and gynaecology, AIIMS Rishikesh
Dehradun
UTTARANCHAL
249201
India |
| Phone |
9690396908 |
| Fax |
|
| Email |
kavita.kh27@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Jaya Chaturvedi |
| Designation |
Professor & Head |
| Affiliation |
AIIMS Rishikesh |
| Address |
Department of obstetrics and gynaecology, AIIMS Rishikesh
Dehradun
UTTARANCHAL
249201
India |
| Phone |
9690396908 |
| Fax |
|
| Email |
jaya_sunil@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Kavita Khoiwal |
| Designation |
Additional Professor |
| Affiliation |
AIIMS Rishikesh |
| Address |
Department of obstetrics and gynaecology, AIIMS Rishikesh
Dehradun
UTTARANCHAL
249201
India |
| Phone |
9690396908 |
| Fax |
|
| Email |
kavita.kh27@gmail.com |
|
|
Source of Monetary or Material Support
|
| AIIMS Rishikesh, Uttarakhand, India-249203 |
|
|
Primary Sponsor
|
| Name |
AIIMS Rishikesh |
| Address |
AIIMS Rishikesh, Uttrakhand - 249203 |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Kavita Khoiwal |
AIIMS Rishikesh |
Department of obstetrics and gynaecology, AIIMS Rishikesh
Dehradun
UTTARANCHAL |
9690396908
kavita.kh27@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| AIIMS Rishikesh |
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 |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Female |
| Details |
1. Histological diagnosis of endometrial cancer.
2. Execution of hysterectomy (with or without salpingo-oophorectomy) with or without
nodal dissection
3. All stages of endometrial carcinoma (I-IV) |
|
| ExclusionCriteria |
| Details |
1. Consent withdrawal
2. Patients with poor-quality slides/blocks (making pathological assessment difficult)
3. Poor quality of DNA obtained |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Number and percentage of cases with positive molecular markers (PoleMutated, MLH1,
MSH2, MSH6, and PMS2, p53 abnormal).
2. Risk stratification based on surgico-pathological risk groups and molecular findings (low,
intermediate, high-intermediate, high, and advanced/metastatic) ESMO-ESGO-ESTRO
2016 and ESGO-ESTRO-ESP 2020 risk group classification.
3. The number of cases that were upstaged or downstaged as per FIGO staging 2009 and
2023. |
Baseline, 1 year, 3 year, 5 years |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Number and percentage of cases who were multiple classifiers.
2. Involvement of myometrium, surgical margins, bilateral adnexa, cervical stroma,
lymphovascular invasion, pelvic or para-aortic lymph nodes vis-a-vis molecular markers.
3. A number of women received adjuvant therapies in the form of brachytherapy, external
beam radiotherapy, or chemoradiation.
4. Kaplan Meier curve for survival statistics.
5. L1CAM, ER, PR, and HER2-neu expression, CTNNB1, PTEN, E-cadherin, ARID1A
mutations. |
2 years |
|
|
Target Sample Size
|
Total Sample Size="150"
Sample Size from India="150"
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)
|
09/12/2024 |
| 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
|
All consecutive biopsy-proven patients with endometrial cancer satisfying eligibility criteria from January 2018 to December 2025 at AIIMS Rishikesh will be included after explaining the objective, procedure, expected outcome, and possible side effects, if any. Written and informed consent will be taken from all prospective participants for the use of their medical records for research purposes. For retrospective cases, permission will be taken from the Medical Superintendent to retrieve data from our institutional database (patient’s clinical records and pathology reports). Demographic characteristics, including body mass index (BMI), menopausal status, parity, performance status, medical comorbidities, clinicopathological, radiological (CT/ MRI) findings, surgical characteristics, and pathology-associated parameters, including histological type, tumor grade, stage of the disease, myometrial invasion, lymph node spread, lymphovascular space invasion, surgical margins, bilateral adnexa, or cervical stroma, will be documented. All pathology slides will be reviewed by pathologists to confirm grade and histotype. The stage will be determined according to the International Federation of Gynecology and Obstetrics (FIGO) 2009 and the recent molecular classification of FIGO 2023. Cinicopathological risk stratification will be done using the ESGO/ESMO/ESTRO consensus
2016. Data will be analyzed for the adjuvant treatment received in the form of brachytherapy, external beam radiotherapy, or chemoradiation. Recurrence pattern, 5-year disease-free survival (only in cases managed till March 2021), and overall survival will be noted. Disease-specific survival will be calculated as the time from surgery to death from endometrial cancer. The cause of death will be mainly based on medical records. Other biomarkers such as L1CAM, ER, PR, and HER2 expression, CTNNB1, PTEN, E-cadherin, and ARID1A mutations will be studied, if feasible, and their association with
prognosis and clinicopathological data will be described. |