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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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.

 
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