Storage of Bile From Routine Procedures to Study Risk Factors

This study is currently recruiting participants.

Verified by Indiana University, August 2009

First Received: December 21, 2006 Last Updated: August 6, 2009 History of Changes

Sponsor:	Indiana University School of Medicine
Information provided by:	Indiana University
ClinicalTrials.gov Identifier:	NCT00414843

Purpose

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
Gallbladder Cancer Cholangiocarcinoma Biliary Tract Cancer

Study Type:	Observational
Official Title:	A Prospective Study of Human Bile and Molecular Predictors of Biliary Malignancy Risk

Resource links provided by NLM:

MedlinePlus related topics: Cancer

U.S. FDA Resources

Further study details as provided by Indiana University:

Biospecimen Retention: Samples Without DNA

Biospecimen Description:

Bile, plasma

Estimated Enrollment:	1000
Study Start Date:	December 2006
Estimated Study Completion Date:	December 2020
Estimated Primary Completion Date:	December 2020 (Final data collection date for primary outcome measure)

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00414843

Contacts

Contact: Mary Maluccio, MD	317-278-1531	mmalucci@iupui.edu
Contact: Sarah Dutkevitch, RN	317-274-5495	sdutkevi@iupui.edu

Locations

United States, Indiana
Indiana University Hospital	Recruiting
Indianapolis, Indiana, United States, 46202
Contact: Mary Maluccio, MD 317-278-1531 mmalucci@iupui.edu
Principal Investigator: Mary Maluccio, MD

Sponsors and Collaborators

Indiana University School of Medicine

Investigators

Principal Investigator:

Mary Maluccio, MD

Indiana University

More Information

No publications provided

Responsible Party:	Indiana University ( Mary Maluccio, Principal Investigator )
Study ID Numbers:	0611-55, IUCRO-0176
Study First Received:	December 21, 2006
Last Updated:	August 6, 2009
ClinicalTrials.gov Identifier:	NCT00414843 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Indiana University:

Storage
Bile
Biomarkers
biliary malignancies

Additional relevant MeSH terms:

Gallbladder Diseases
Cholangiocarcinoma
Biliary Tract Neoplasms
Digestive System Neoplasms
Neoplasms by Histologic Type
Carcinoma
Neoplasms

Neoplasms by Site
Digestive System Diseases
Biliary Tract Diseases
Gallbladder Neoplasms
Adenocarcinoma
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on March 18, 2010