| CTRI Number |
CTRI/2025/03/083162 [Registered on: 24/03/2025] Trial Registered Prospectively |
| Last Modified On: |
21/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
How genetic changes affect the occurrence and outlook of endometrial cancer |
|
Scientific Title of Study
|
Incidence and prognostic impact of genomic alteration in endometrial cancer |
| 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 Inimerla Bhavya |
| Designation |
Senior Resident |
| Affiliation |
Institute of Medical sciences and SUM Hospital |
| Address |
Department of Medical Oncology Institute of Medical sciences and SUM Hospital Siksha O Anusandhan Kalinga Nagar Ghatikia
Khordha
ORISSA
751003
India |
| Phone |
9110590286 |
| Fax |
|
| Email |
bavvychandrika@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ghanashyam Biswas |
| Designation |
Professor |
| Affiliation |
Institute of Medical sciences and SUM Hospital |
| Address |
Department of Medical Oncology Institute of Medical sciences and SUM Hospital Siksha O Anusandhan Kalinga Nagar Ghatikia
Khordha
ORISSA
751003
India |
| Phone |
9937500878 |
| Fax |
|
| Email |
drgbiswas@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Inimerla Bhavya |
| Designation |
Senior Resident |
| Affiliation |
Institute of Medical sciences and SUM Hospital |
| Address |
Department of Medical Oncology Institute of Medical sciences and SUM Hospital Siksha O Anusandhan Kalinga Nagar Ghatikia
Khordha
ORISSA
751003
India |
| Phone |
9110590286 |
| Fax |
|
| Email |
bavvychandrika@gmail.com |
|
|
Source of Monetary or Material Support
|
| Institute of Medical sciences and SUM Hospital, Siksha O Anusandhan University |
|
|
Primary Sponsor
|
| Name |
Dr Inimerla Bhavya |
| Address |
Department of Medical Oncology Institute of Medical sciences and SUM Hospital Siksha O Anusandhan Kalinga Nagar Ghatikia, Bhubaneswar 751003, Khordha |
| Type of Sponsor |
Other [Self] |
|
|
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 Inimerla Bhavya |
Institute of Medical sciences and SUM Hospital |
Department of Medical Oncology Kalinga Nagar Ghatikia
Bhubaneswar
Khordha
Khordha
ORISSA |
9110590286
bavvychandrika@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE INSTITUTE OF MEDICAL SCIENCES (IMS) AND SUM HOSPITAL Siksha O Anusandhan (Deemed to be University) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C55||Malignant neoplasm of uterus, partunspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Female |
| Details |
All cases of endometrial carcinoma attending medical oncology and surgical oncology OPD irrespective of stage. |
|
| ExclusionCriteria |
| Details |
Patients who refuse to take part in this study.
Patients with other confounding factors such as prior radiation to pelvis, concomitant malignancy, HCV/HBsAg/HIV reactive, active TB, previously treated different malignancy.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To determine the incidence of various genomic mutations ( POLE, MSI and TP53 status )in EC by genetic analysis. |
3 monthly and 6 monthly |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To analyze the clinical outcomes and correlate them with various mutations according to histological variants of EC.
To analyze the outcome of POLE mutation, MSI, and TP53 in patients of EC.
|
3 monthly and 6 monthly |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
03/04/2026 |
| 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="1"
Months="6"
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
|
The project titled Incidence
and Prognostic Impact of Genomic Alteration in Endometrial Cancer aims to
determine the incidence of genetic mutations (POLE, MSI, and TP53) in
endometrial carcinoma (EC) and analyze their correlation with clinical
outcomes. This study will focus on patients diagnosed with EC at the Medical
Oncology and Surgical Oncology OPD of IMS and SUM Hospital. The research will
explore how these genomic alterations impact prognosis. Statistical analysis using SPSS and Kaplan-Meier methods will help
assess survival outcomes and mutational patterns, contributing to improved
treatment strategies.
|