| CTRI Number |
CTRI/2025/10/095713 [Registered on: 08/10/2025] Trial Registered Prospectively |
| Last Modified On: |
07/10/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
A study to understand the pattern and treatment outcomes of bile duct cancer among patients registered at a tertiary care centre. |
|
Scientific Title of Study
|
IDH1 Biliary Tract Cancer (BTC) Registry |
| Trial Acronym |
BTC registry |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Bhawna Sirohi |
| Designation |
Medical Director |
| Affiliation |
Vedanta Medical Research Foundation (BALCO Medical Centre) |
| Address |
Room No 4, Medical Oncology OPD, Ground Floor, B wind, BALCO Medical Centre Sector 36, Atal Nagar, PO Uparwara, Raipur, Chhattisgarh,
Raipur CHHATTISGARH 493661 India |
| Phone |
9756999976 |
| Fax |
|
| Email |
bhawna.sirohi@vedanta.co.in |
|
Details of Contact Person Scientific Query
|
| Name |
Bhawna Sirohi |
| Designation |
Medical Director |
| Affiliation |
Vedanta Medical Research Foundation (BALCO Medical Centre) |
| Address |
Room No 4, Medical Oncology OPD, Ground Floor, B wind, BALCO Medical Centre Sector 36, Atal Nagar, PO Uparwara, Raipur, Chhattisgarh,
Raipur CHHATTISGARH 493661 India |
| Phone |
9756999976 |
| Fax |
|
| Email |
bhawna.sirohi@vedanta.co.in |
|
Details of Contact Person Public Query
|
| Name |
Bhawna Sirohi |
| Designation |
Medical Director |
| Affiliation |
Vedanta Medical Research Foundation (BALCO Medical Centre) |
| Address |
Room No 4, Medical Oncology OPD, Ground Floor, B wind, BALCO Medical Centre Sector 36, Atal Nagar, PO Uparwara, Raipur, Chhattisgarh,
Raipur CHHATTISGARH 493661 India |
| Phone |
9756999976 |
| Fax |
|
| Email |
bhawna.sirohi@vedanta.co.in |
|
|
Source of Monetary or Material Support
|
| BALCO Medical Center, Sector 36, Atal Nagar, PO Uparwara, Raipur, Chhattisgarh, India 493661
|
|
|
Primary Sponsor
|
| Name |
Vedanta Medical Research Foundation |
| Address |
Balco Medical Centre, Sector 36, Atal Nagar, PO Uparwara, Raipur, Chhattisgarh, India 493661 |
| Type of Sponsor |
Private hospital/clinic |
|
|
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 |
| Bhawna Sirohi |
BALCO Medical Centre |
Room no 4, Medical Oncology, Sector 36, Atal Nagar, PO: Uparwara, Raipur, Chhattisgarh 493661 Raipur CHHATTISGARH |
9756999976
bhawna.sirohi@vedanta.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| BALCO Medical Centre- Institutional Review Board (BMC-IRB) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C22||Malignant neoplasm of liver and intrahepatic bile ducts, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
The study will include histopathologically confirmed metastatic Biliary tract cancer patients, who were undergoing treatment or at follow-up visit to the hospital during the study period.
All adult patients who are aged 18 and above with biliary tract cancer and are willing to participate in the study.
|
|
| ExclusionCriteria |
| Details |
Patients who are below 18 years and are not willing to participate. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To describe the profile and patterns of Biliary Tract cancer in patients availing of care at the reporting hospital.
|
This is an observational study without any intervention. Data will be assessed for all registered patients during two time periods:
1)Retrospective phase: March 2018 to September 2025
2)Prospective phase: October 2025 to June 2027 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Screen eligible patients & abstract medical records to describe the diagnostic, staging, & treatment details of Biliary Tract cancer patients. |
24 Weeks |
|
|
Target Sample Size
|
Total Sample Size="200000" Sample Size from India="200000"
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)
|
31/10/2025 |
| 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="2" Months="5" Days="0" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
Biliary tract cancers (BTCs) are a heterogeneous group of highly aggressive, lethal malignancies that are characterized by genomic differences among tumors from different anatomic sites. It is often diagnosed at an advanced stage, and even when resectable at an earlier stage, its high recurrence rate leads to a poor prognosis. India has a high burden of biliary tract tumors, particularly gall bladder cancer (GBC), the incidence is 10 times higher in northern India compared to the southern Indian states and with a significant geographic variance. In India, the young population is affected more in the fifth and sixth decades of life. The deadly nature of BTC, with high mortality rates, is alarmingly high, with only 20% of patients surviving beyond 5 years after diagnosis, posing a significant challenge to the healthcare community. The increasing number of BTC cases is linked to several risk factors, so understanding the epidemiological factors and molecular characterization of BTCs provides potentially actionable clinical information, which may help in clinical development of therapies targeting actionable alterations with the overall ultimate goal of improving clinical outcomes. The objective of the study is to understand the epidemiological patterns, clinical characteristics, treatment outcomes and molecular characteristics in biliary tract cancers. |