Back to resultsStorage of Bile From Routine Procedures to Study Risk Factors
Primary Purpose
Gallbladder Cancer, Cholangiocarcinoma, Biliary Tract Cancer
Status
Terminated
Phase
Locations
United States
Study Type
Observational
Intervention
Sponsored by
About this trial
This is an observational trial for Gallbladder Cancer focused on measuring Storage, Bile, Biomarkers, biliary malignancies
Eligibility Criteria
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
Sites / Locations
- Indiana University Hospital
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT00414843
First Posted
December 21, 2006
Last Updated
February 22, 2016
Sponsor
Indiana University School of Medicine
1. Study Identification
Unique Protocol Identification Number
NCT00414843
Brief Title
Storage of Bile From Routine Procedures to Study Risk Factors
Official Title
A Prospective Study of Human Bile and Molecular Predictors of Biliary Malignancy Risk
Study Type
Observational
2. Study Status
Record Verification Date
February 2016
Overall Recruitment Status
Terminated
Why Stopped
Decreasing interest in using samples; department infrastructure waned
Study Start Date
December 2006 (undefined)
Primary Completion Date
August 2015 (Actual)
Study Completion Date
August 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Indiana University School of Medicine
4. Oversight
5. Study Description
Brief 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.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gallbladder Cancer, Cholangiocarcinoma, Biliary Tract Cancer
Keywords
Storage, Bile, Biomarkers, biliary malignancies
7. Study Design
Enrollment
390 (Actual)
Biospecimen Retention
Samples Without DNA
Biospecimen Description
Bile, plasma
Primary Outcome Measure Information:
Title
Establish Repository of Human Bile
Description
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.
Time Frame
2024
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 Population Description
Subjects presenting to Indiana University for treatment of biliary tract disease.
Sampling Method
Non-Probability Sample
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mary Maluccio, MD
Organizational Affiliation
Indiana University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Indiana University Hospital
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Storage of Bile From Routine Procedures to Study Risk Factors
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