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Storage of Bile From Routine Procedures to Study Risk Factors

Sponsor
Indiana University School of Medicine (Other)
Overall Status
Terminated
CT.gov ID
NCT00414843
Collaborator
(none)
390
Enrollment
1
Location
104
Duration (Months)
3.8
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Actual Enrollment :
    390 participants
    Official Title:
    A Prospective Study of Human Bile and Molecular Predictors of Biliary Malignancy Risk
    Study Start Date :
    Dec 1, 2006
    Actual Primary Completion Date :
    Aug 1, 2015
    Actual Study Completion Date :
    Aug 1, 2015

    Outcome Measures

    Primary Outcome Measures

    1. Establish Repository of Human Bile [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Indiana University Hospital Indianapolis Indiana United States 46202

    Sponsors and Collaborators

    • Indiana University School of Medicine

    Investigators

    • Principal Investigator: Mary Maluccio, MD, Indiana University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Indiana University School of Medicine
    ClinicalTrials.gov Identifier:
    NCT00414843
    Other Study ID Numbers:
    • 0611-55
    • IUCRO-0176
    First Posted:
    Dec 22, 2006
    Last Update Posted:
    Feb 23, 2016
    Last Verified:
    Feb 1, 2016
    Keywords provided by Indiana University School of Medicine
    Storage
    Bile
    Biomarkers
    biliary malignancies
    Additional relevant MeSH terms:
    Cholangiocarcinoma
    Biliary Tract Neoplasms
    Gallbladder Neoplasms

    Study Results

    No Results Posted as of Feb 23, 2016