| CTRI Number |
CTRI/2025/10/095523 [Registered on: 01/10/2025] Trial Registered Prospectively |
| Last Modified On: |
29/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
Study on Treatment Outcomes and Use of Next-Generation Gene Testing in Patients with Malignant Peritoneal Mesothelioma: A retrospective |
|
Scientific Title of Study
|
Retrospective analysis of clinical outcome and clinical next-generation sequencing application in malignant peritoneal mesothelioma patients treated in a tertiary cancer care center in India |
| Trial Acronym |
COMET study |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NA |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Prabhat Ghanshyam Bhargava |
| Designation |
Professor of Medical Oncology |
| Affiliation |
Tata Memorial Hospital |
| Address |
11th floor 1106, Homi Bhabha Building, Tata Memorial Hospital, Dr. Ernest Borges Road , Parel Mumbai 400012
Mumbai
MAHARASHTRA
400012
India |
| Phone |
07276174221 |
| Fax |
|
| Email |
bhargava611@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Dharmpal Jakhar |
| Designation |
Assistant Professor of Medical Oncology |
| Affiliation |
Tata Memorial Hospital |
| Address |
Tata Memorial Hospital, Homi Bhabha Building, Department of Medical Oncology , Dr. Ernest Borges Road , Parel Mumbai 400012
Mumbai
MAHARASHTRA
400012
India |
| Phone |
7878530692 |
| Fax |
|
| Email |
doctor.dharmpal32@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Prabhat Ghanshyam Bhargava |
| Designation |
Professor of Medical Oncology |
| Affiliation |
Tata Memorial Hospital |
| Address |
11th floor 1106, Homi Bhabha Building, Tata Memorial Hospital, Dr. Ernest Borges Road , Parel Mumbai 400012
Mumbai
MAHARASHTRA
400012
India |
| Phone |
07276174221 |
| Fax |
|
| Email |
bhargava611@gmail.com |
|
|
Source of Monetary or Material Support
|
| Tata Memorial Hospital, Dr. Ernest Borges Road, Parel, Mumbai 400012 |
|
|
Primary Sponsor
|
| Name |
Tata Memorial Hospital |
| Address |
11 Floor 1106, Homi Bhabha Block , Tata Memorial Hospital , Dr. Ernest Borges Road , Parel Mumbai 400012 |
| 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 Prabhat Ghanshyam Bhargava |
Tata Memorial Hospital |
1106 , 11th Floor Homi Bhabha Building,Department of Medical Oncology,Tata Memorial Hospital, Dr. Ernest Borges Road, Parel Mumbai 400012
Mumbai
MAHARASHTRA |
07276174221
bhargava611@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee-II |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C457||Mesothelioma of other sites, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Age between 18 and 70 years at the time of diagnosis.
2. Histopathological confirmation of malignant peritoneal mesothelioma.
3. Receipt of treatment/ treatment plan (systemic chemotherapy, surgery, or both) from TMH, Parel
|
|
| ExclusionCriteria |
| Details |
1. Patients who were diagnosed at TMH but received treatment elsewhere.
2. Incomplete clinical records.
3. Availability of formalin-fixed paraffin-embedded (FFPE) tumor tissue blocks at TMH for genomic analysis is not compulsory.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To study the overall survival of the peritoneal mesothelioma. |
date of diagnosis till date of death: baseline till patient date of death |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To study the progression-free survival of peritoneal mesothelioma patients.
|
baseline till PD |
| Baseline demographic characteristics of peritoneal mesothelioma patients. |
basline |
| Molecular Characterization Analysis by NGS. |
Baseline
|
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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)
|
01/09/2026 |
| 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="10"
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
|
Study design: Retrospective study Study setting: Medical Oncology Parel, TMH, and ACTREC, Kharghar Study duration: January 2014 to December 2023 Study population: Patients with peritoneal mesothelioma treated in Parel TMH in the determined time period Study methodology: It is a hospital based retrospective study. All the patients who received treatment at Parel TMH from January 2014 to December 2023 will be analyzed. All data will be collected from the electronic medical record of the hospital. The details will be captured as mentioned in the case report form. Objectives: - Primary objective: To study the survival outcomes of malignant peritoneal mesothelioma patients
- Secondary objective: To analyze the baseline demographic characteristics of peritoneal mesothelioma patients and to assess the molecular characteristics of peritoneal mesothelioma patients by using NGS
Sample size: 60 to 70 patients who underwent treatment from January 2014 to December 2023 will be included in this study Molecular analysis: NGS will be performed on formalin fixed paraffin embedded tissue Ethics: Waiver of consent is requested as the study involves less than minimal risk and there is no direct contact between the researcher and the participant Statistical analysis: Descriptive statistics for demographic and clinical variables will be performed. Kaplan Meier method will be used for survival analysis. The data will be analyzed in IBM SPSS v25
|