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CTRI Number  CTRI/2024/05/067223 [Registered on: 13/05/2024] Trial Registered Prospectively
Last Modified On: 11/05/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Case Control Study 
Study Design  Other 
Public Title of Study   Analysis of bile for gall bladder and bile duct cancers. 
Scientific Title of Study   Diagnostic value of cell free tumor DNA in bile and its relation to biliary bile acids for Biliary Tract Carcinoma. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Veluru Gautham 
Designation  Senior Resident 
Affiliation  Institute of Liver and Biliary Sciences 
Address  Dr Veluru Gautham, Department of HPB surgery and Liver Transplant, Institute of Liver and Biliary Sciences, Vasant Kunj, New Delhi

South West
DELHI
110070
India 
Phone  9440346072  
Fax    
Email  veluru.gautham2@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Nihar Ranjan Mohapatra 
Designation  Assistant Professor 
Affiliation  Institute of Liver and Biliary Sciences 
Address  Dr Nihar Ranjan Mohapatra, Department of HPB surgery and Liver Transplant, Institute of Liver and Biliary Sciences, Vasant Kunj, New Delhi.

South West
DELHI
110070
India 
Phone  9910479799  
Fax    
Email  NIHAR0310@GMAIL.COM  
 
Details of Contact Person
Public Query
 
Name  Dr Nihar Ranjan Mohapatra 
Designation  Assistant Professor 
Affiliation  Institute of Liver and Biliary Sciences 
Address  Dr Nihar Ranjan Mohapatra, Department of HPB surgery and Liver Transplant, Institute of Liver and Biliary Sciences, Vasant Kunj, New Delhi.

South West
DELHI
110070
India 
Phone  9910479799  
Fax    
Email  NIHAR0310@GMAIL.COM  
 
Source of Monetary or Material Support  
Institute of liver and Biliary sciences, Vasant Kunj, New Delhi, India Pin: 110070 
 
Primary Sponsor  
Name  Institute of liver and biliary sciences 
Address  Institute of liver and biliary sciences, Vasant Kunj, New Delhi 110070 
Type of Sponsor  Other [Institute of liver and Biliary sciences] 
 
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 
Dr Veluru Gautham  Institute of liver and biliary sciences  Department of HPB surgery and liver transplant, Institute of liver and biliary sciences, Vasant Kunj, New Delhi, PIN: 110070
South West
DELHI 
9440346072

veluru.gautham2@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee (IEC)/ Institutional review Board (IRB), Institute of Liver and Biliary sciences.  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
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  80.00 Year(s)
Gender  Both 
Details  All biliary tract carcinomas, benign biliary diseases with high risk features for biliary carcinomas, symptomatic Gallstone disease. 
 
ExclusionCriteria 
Details  Negative consent
Inability to collect adequate bile sample. 
 
Method of Generating Random Sequence    
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
Total cell free DNA
Genetic mutations in bile cell free tumor DNA. 
one year 
 
Secondary Outcome  
Outcome  TimePoints 
Proportion of primary and secondary and tertiary bile acids in bile.
Histopathological staging and grading and level of tumor markers of the Biliary tract cancers. 
one year 
 
Target Sample Size   Total Sample Size="90"
Sample Size from India="90" 
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)   22/05/2024 
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="6"
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  

Biliary tract carcinoma includes gallbladder carcinoma, intrahepatic cholangiocarcinoma, hilar cholangiocarcinoma and distal cholangiocarcinoma. (1) The 5 year survival rate is <10% in patients with advanced or metastatic BTCs (2). Most patients are ineligible for surgical resection at the time of diagnosis of BTC (3). Since the current treatments are minimally effective, a multi-omic approach combining genomic, transcriptomic, and metabolomic landscapes would be beneficial and could lead to earlier diagnosis and improved treatment. In addition, the etiological role of biliary bile acids in biliary tract carcinomas still remains equivocal. This trial aims to analyze the utility of biliary cell free DNA for the diagnosis of BTCs, and correlation of biliary cell free DNA and relative proportions of  biliary bile acids in biliary tract carcinoma. All eligible patients who have biliary tract carcinomas (BTC), benign biliary diseases with high risk for BTC and symptomatic gallstone disease during the study period will be included in the study. Bile samples collected at the time of surgery or at the time of interventional procedures like PTBD, ENBD, ERCP, will be analyzed for cell free tumor DNA (cft DNA) and biliary bile acids. The collected bile samples will be stored at -20 degrees Celsius. The cell free tumor DNA (cft DNA) in bile is analyzed using NGS through a somatic panel of 16 genes. Biliary bile acids (Total bile acids, Cholic acid, Chenodeoxycholic acid, Deoxycholic acid, Lithocholic acid and Ursodeoxycholic acid) are analyzed using LCMS.

 
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