Storage of Bile From Routine Procedures to Study Risk Factors

Cholangiocarcinoma Clinical Trial

Official title:

A Prospective Study of Human Bile and Molecular Predictors of Biliary Malignancy Risk

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00414843
• Other study ID #: 0611-55
• Secondary ID: IUCRO-0176
• Status: Terminated
• Phase: N/A
• First received: December 21, 2006
• Last updated: February 22, 2016
• Start date: December 2006
• Est. completion date: August 2015

Study information

• Verified date: February 2016
• Source: Indiana University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

The purpose of the study is to establish a repository of human bile as a resource for studies evaluating molecular predictors of biliary cancer risk.

Description:

The specific aim of this study is to establish a repository of human bile to serve as a resource for studies looking at molecular predictors of biliary tract cancer. The development of fluid based biomarkers will enable early diagnosis in at-risk individuals with a recognized risk factor for cholangiocarcinoma, as well as provide surveillance mechanisms for screening populations where biliary tract cancer has a high incidence.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 390
• Est. completion date: August 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Presenting to IU for treatment of biliary tract disease; Age greater than or equal to 18

Exclusion Criteria:

• Problems other than biliary tract disease

Study Design

N/A

Related Conditions & MeSH terms

• Biliary Tract Cancer
• Biliary Tract Neoplasms
• Cholangiocarcinoma
• Gallbladder Cancer

Locations

Country	Name	City	State
United States	Indiana University Hospital	Indianapolis	Indiana

Sponsors (1)

Lead Sponsor	Collaborator
Indiana University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Establish Repository of Human Bile	Establish a repository of human bile that will serve as a resource through which studies can be performed looking at molecular predictors of biliary tract cancer risk.	2024	No