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Storage of Bile From Routine Procedures to Study Risk Factors

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ClinicalTrials.gov Identifier: NCT00414843
Recruitment Status : Terminated (Decreasing interest in using samples; department infrastructure waned)
First Posted : December 22, 2006
Last Update Posted : February 23, 2016
Sponsor:
Information provided by (Responsible Party):
Indiana University ( Indiana University School of Medicine )

Study Description
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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
Gallbladder Cancer Cholangiocarcinoma Biliary Tract Cancer

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
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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 : December 2006
Actual Primary Completion Date : August 2015
Actual Study Completion Date : August 2015

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Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. 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.


Biospecimen Retention:   Samples Without DNA
Bile, plasma

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Subjects presenting to Indiana University for treatment of biliary tract disease.
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
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00414843


Locations
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United States, Indiana
Indiana University Hospital
Indianapolis, Indiana, United States, 46202
Sponsors and Collaborators
Indiana University School of Medicine
Investigators
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Principal Investigator: Mary Maluccio, MD Indiana University
More Information
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Responsible Party: Indiana University School of Medicine
ClinicalTrials.gov Identifier: NCT00414843    
Other Study ID Numbers: 0611-55
IUCRO-0176
First Posted: December 22, 2006    Key Record Dates
Last Update Posted: February 23, 2016
Last Verified: February 2016
Keywords provided by Indiana University ( Indiana University School of Medicine ):
Storage
Bile
Biomarkers
biliary malignancies
Additional relevant MeSH terms:
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Cholangiocarcinoma
Biliary Tract Neoplasms
Gallbladder Neoplasms
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
 Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Biliary Tract Diseases
Digestive System Diseases
Gallbladder Diseases