| CTRI Number |
CTRI/2024/09/073653 [Registered on: 09/09/2024] Trial Registered Prospectively |
| Last Modified On: |
17/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
An observational study to see association of complete cytoreductive surgery with BRCA mutation status in ovarian cancer patient |
|
Scientific Title of Study
|
An observational study exploring the association of the completeness of cytoreductive surgery and surgical complexity score with the BRCA mutation status in patients with high grade serous ovarian 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 |
Basumita Chakraborti |
| Designation |
Consultant |
| Affiliation |
Tata Medical Center, Kolkata |
| Address |
Tata Medical center
TTRC building 1st floor, Department of Gynecological oncology, Room number 105
14 MAR(EW), NewTown, Rajarhat, Kolkata
Kolkata
WEST BENGAL
700160
India |
| Phone |
9831214090 |
| Fax |
|
| Email |
sanjaybasumita@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Basumita Chakraborti |
| Designation |
Consultant |
| Affiliation |
Tata Medical Center, Kolkata |
| Address |
Tata Medical center,
TTRC building 1st floor, Department of Gynecological oncology, Room number 105
14 MAR(EW), NewTown, Rajarhat, Kolkata
Kolkata
WEST BENGAL
700160
India |
| Phone |
9831214090 |
| Fax |
|
| Email |
sanjaybasumita@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
G. Raja |
| Designation |
DrNB SS Trainee |
| Affiliation |
Tata Medical Center, Kolkata |
| Address |
Tata Medical center,
TTRC building 1st floor, Department of Gynecological oncology, Room number 105
14 MAR(EW), NewTown, Rajarhat, Kolkata
Kolkata
WEST BENGAL
700160
India |
| Phone |
9831214090 |
| Fax |
|
| Email |
mallanagouda291993@gmail.com |
|
|
Source of Monetary or Material Support
|
| Tata Medical center Kolkata
14 MAR, DH Block(Newtown), Action Area I, Newtown, Kolkata, Chakpachuria, West Bengal, India 700160
|
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
NIL |
| Type of Sponsor |
Other [NIL] |
|
|
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 G Raja |
Tata Medical Centre Kolkata |
Phase one ground floor,
Department of Gynecological oncology
Joint clinic 2, Room no.13,14,19
14 MAR(EW), NewTown, Rajarhat, Kolkata
14 MAR (E-W) Newtown, Rajarhat, Kolkata 700160 West Bengal, India
Kolkata
WEST BENGAL |
7019499425
mallanagouda291993@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| TATA medical center Institutional review board |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C570||Malignant neoplasm of fallopian tube, (2) ICD-10 Condition: C569||Malignant neoplasm of unspecifiedovary, (3) ICD-10 Condition: C577||Malignant neoplasm of other specified female genital organs, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Female |
| Details |
1. High grade serous ovarian cancer (HGSOC) patients
who had primary surgery which includes primary
debulking surgery, interval debulking surgery
and completion surgery at Tata Medical Center
Kolkata
2. More than 18 years of age
|
|
| ExclusionCriteria |
| Details |
1. Epithelial ovarian cancers other than HGSOC and
non-epithelial ovarian cancer patients.
2. Repeat cytoreductive surgery after disease
recurrence.
3. Less than 18 years |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
|
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Primary outcome- To determine the association of germline BRCA mutations with rates of complete cytoreduction
|
Final analysis of association between complete cytoreduction and BRCA mutation status will be done after complete recruitement of sample size that is in December 2025 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To determine the association of germline BRCA mutation with surgical complexity score.
To estimate the progression free survival (PFS) & overall survival (OS) in the above cohort of patients |
OS PFS analysed after 6 months of follow-up after completion of treatment
association of BRCA mutation status with Surgical complexity score will be analysed after complete recruitement of sample size |
|
|
Target Sample Size
|
Total Sample Size="287"
Sample Size from India="287"
Final Enrollment numbers achieved (Total)= "287"
Final Enrollment numbers achieved (India)="287" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
17/09/2024 |
| Date of Study Completion (India) |
31/12/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
31/01/2026 |
|
Estimated Duration of Trial
|
Years="1"
Months="11"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
Background: Ovarian cancer is the leading cause of death among women with all gynecological cancers. Around 15-20% of high-grade serous ovarian carcinomas (HGSOC) are associated with BRCA mutation. BRCA-associated HGSOC have better overall survival (OS). It is already established that they respond better to platinum-based chemotherapy. The primary treatment in ovarian cancer is surgery and residual tumour after surgery is an independent prognostic factor for OS. Unique histology of BRCA mutated HGSOC might allow for complete resectability of tumor. Our study aims to find the association between germline BRCA mutation and complete cytoreduction at surgery. Aim:This study aims to investigate whether BRCA mutation is an independent predictor for complete cytoreduction in HGSOC. Materials and methods: The patients of HGSOC evaluated and operated in TMCK and having been tested for germline mutation from the Institution will be included in this study. The patients will be compared depending on the presence or absence of BRCA germline mutations. The prospective study will be for twenty-three months from March 2024 to October 2025, including data collection and data analysis with a minimum of 3 months follow up. To complete the sample size of 287 patients, surgical data will be collected from 01/01/23 onwards. The data on demographic details, germline mutations, intraoperative details regarding complete cytoreduction (CC) scores, surgical complexity scores (SCS), intraoperative and postoperative complications will be collected from prospectively maintained retrospective records in the hospital electronic medical records. The follow-up data will be collected prospectively following departmental protocol for OS and PFS. Descriptive statistics will be elaborated in the form of means and standard deviations and medians and IQRs for continuous variables, and frequencies and percentages for categorical variables. The association of BRCA mutation with completeness of cytoreduction will be assessed by linear correlation using Pearson’s correlation or Spearman’s correlation
|