| CTRI Number |
CTRI/2025/07/090747 [Registered on: 11/07/2025] Trial Registered Prospectively |
| Last Modified On: |
09/07/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
An observational single-centre study to find out does regular monitoring of a specialised blood test ( serum Ca 19.9 measurement) helps in the early detection of recurrence of gallbladder cancer after surgery. |
|
Scientific Title of Study
|
The Role of Serial Serum Carbohydrate Antigen 19-9 Surveillance to Detect Recurrences after Radical Curative Resection for Gallbladder Carcinoma |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Project no 4832 V 1.0_4 May 2025 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Shraddha Patkar |
| Designation |
Professor and Hepato-Billiary Surgon |
| Affiliation |
Tata Memorial Hospital, Mumbai |
| Address |
Room no 324, Gastro-Intestinal Disease Managemnt Group, 3rd Floor, Homi Bhabha Building, Dr E Borges Road
Mumbai
MAHARASHTRA
400012
India |
| Phone |
9820074818 |
| Fax |
|
| Email |
drshraddhapatkar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shraddha Patkar |
| Designation |
Professor and Hepato-Billiary Surgon |
| Affiliation |
Tata Memorial Hospital, Mumbai |
| Address |
Room no 324, Gastro-Intestinal Disease Managemnt Group, 3rd Floor, Homi Bhabha Building, Dr E Borges Road
MAHARASHTRA
400012
India |
| Phone |
9820074818 |
| Fax |
|
| Email |
drshraddhapatkar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shraddha Patkar |
| Designation |
Professor and Hepato-Billiary Surgon |
| Affiliation |
Tata Memorial Hospital, Mumbai |
| Address |
Room no 324, Gastro-Intestinal Disease Managemnt Group, 3rd Floor, Homi Bhabha Building, Dr E Borges Road
MAHARASHTRA
400012
India |
| Phone |
9820074818 |
| Fax |
|
| Email |
drshraddhapatkar@gmail.com |
|
|
Source of Monetary or Material Support
|
| Tata Memorial Hospital, Dr E borges Road, Parel, Mumbai, Maharashtra, India-400012 |
|
|
Primary Sponsor
|
| Name |
Tata Memorial Hospital |
| Address |
Dr E Borges Road, Parel, Mumbai, Maharashtra, India 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 Shraddha Patkar |
Tata Memorial Hospital, Mumbai |
OPD no 324, Gastro-Intestinal Disease Management Group, 3rd Floor, Homi Bhabha Building, Dr E Borges Road, Parel
Mumbai
MAHARASHTRA |
9820074818
drshraddhapatkar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Tata Memorial Hospital Institutional Ethics Committee-II |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C23||Malignant neoplasm of gallbladder, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1. Consecutive adult patients more than 18 years of both sexes with Gallbladder carcinoma who underwent curative radical resection
2. Date of surgery between 01 Jan 2010 to 31Jan2024
|
|
| ExclusionCriteria |
| Details |
1. Date of surgery outside the study period
2. Patients with non-malignant pathology, non-adenocarcinoma histology, metastatic disease, non-radical surgery, and R plus resections.
3.CA 19-9 non-secretors (undetectable serum CA 19-9 levels less than 2 U per ml)
Patients who have no post-operative CA 19-9 values available
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The sensitivity, and specificity for the first raised postoperative CA 19-9 level, the serial rise in serum CA 19-9, and the relative rise and absolute cut-off value of serum CA 19-9 for the diagnosis of recurrence |
6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The positive predictive value, and negative predictive value for the first raised postoperative CA 19-9 level, the serial rise in serum CA 19-9, and the relative rise and absolute cut-off value of serum CA 19-9 for the diagnosis of recurrence. |
6 months |
|
|
Target Sample Size
|
Total Sample Size="813"
Sample Size from India="813"
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)
|
28/07/2025 |
| 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="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
|
Gallbladder carcinoma (GBC) is the most common type of biliary tract cancer associated with poor outcome, especially when detected at an advanced stage. Owing to their aggressive behavior, even after surgery meant to completely remove the tumor and additional treatments like chemotherapy or radiation, this cancer often comes back. Timely detection of cancer recurrence is important because it allows consideration of second-line treatment, which can help control the disease, relieve symptoms, and possibly extend survival compared to only providing comfort care. Regular check-ups and follow-ups are key to early detection of recurrence. One possible tool for detecting recurrence is a blood test that measures carbohydrate antigen 19-9 (CA 19-9) – a substance that can be higher in people with gall bladder or pancreatic cancer. Although this test is widely used for surveillance in pancreatic cancer, its role in GBC surveillance is not yet well established. The present study looks at whether serial monitoring of serum CA 19-9 helps early detection of recurrence in GBC who underwent curative radical resection.
|