Storage of Bile From Routine Procedures to Study Risk Factors

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Indiana University
Sponsor:
Information provided by (Responsible Party):
Indiana University ( Indiana University School of Medicine )
ClinicalTrials.gov Identifier:
NCT00414843
First received: December 21, 2006
Last updated: July 1, 2014
Last verified: July 2014

December 21, 2006
July 1, 2014
December 2006
December 2020   (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.
 
Recruiting
1000
December 2020
December 2020   (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
No
Contact: Mary Maluccio, MD 317-948-5239 mmalucci@iupui.edu
Contact: Sarah Dutkevitch, RN 317-274-5495 sdutkevi@iupui.edu
United States
 
NCT00414843
0611-55, IUCRO-0176
No
Indiana University ( Indiana University School of Medicine )
Indiana University School of Medicine
Not Provided
Principal Investigator: Mary Maluccio, MD Indiana University
Indiana University
July 2014

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