Storage of Bile From Routine Procedures to Study Risk Factors

This study has been terminated.
(Decreasing interest in using samples; department infrastructure waned)
Sponsor:
Information provided by (Responsible Party):
Indiana University ( Indiana University School of Medicine )
ClinicalTrials.gov Identifier:
NCT00414843
First received: December 21, 2006
Last updated: February 22, 2016
Last verified: February 2016

December 21, 2006
February 22, 2016
December 2006
August 2015   (final data collection date for primary outcome measure)
Establish Repository of Human Bile [ Time Frame: 2024 ] [ Designated as safety issue: No ]
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.
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Complete list of historical versions of study NCT00414843 on ClinicalTrials.gov Archive Site
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Storage of Bile From Routine Procedures to Study Risk Factors
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.
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.
Observational
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Retention:   Samples Without DNA
Description:
Bile, plasma
Non-Probability Sample
Subjects presenting to Indiana University for treatment of biliary tract disease.
  • Gallbladder Cancer
  • Cholangiocarcinoma
  • Biliary Tract Cancer
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
390
August 2015
August 2015   (final data collection date for primary outcome measure)

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
Both
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00414843
0611-55, IUCRO-0176
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Indiana University School of Medicine
Indiana University School of Medicine
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Principal Investigator: Mary Maluccio, MD Indiana University
Indiana University
February 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP