Storage of Bile From Routine Procedures to Study Risk Factors

February 22, 2016 updated by: Indiana University School of Medicine

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

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.

Study Overview

Status

Terminated

Conditions

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.

Study Type

Observational

Enrollment (Actual)

390

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Indiana University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Subjects presenting to Indiana University for treatment of biliary tract disease.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Establish Repository of Human Bile
Time Frame: 2024
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Indiana University School of Medicine

Investigators

  • Principal Investigator: Mary Maluccio, MD, Indiana University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2006

Primary Completion (Actual)

August 1, 2015

Study Completion (Actual)

August 1, 2015

Study Registration Dates

First Submitted

December 21, 2006

First Submitted That Met QC Criteria

December 21, 2006

First Posted (Estimate)

December 22, 2006

Study Record Updates

Last Update Posted (Estimate)

February 23, 2016

Last Update Submitted That Met QC Criteria

February 22, 2016

Last Verified

February 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0611-55
  • IUCRO-0176

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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