| 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
|
|
|
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
|
|
|
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. |