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
  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:


Further study details as provided by Indiana University:

Primary Outcome Measures:
  • 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.


Biospecimen Retention:   Samples Without DNA

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Contacts
Contact: Mary Maluccio, MD 317-948-5239 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    317-948-5239    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 ( Indiana University School of Medicine )
ClinicalTrials.gov Identifier: NCT00414843     History of Changes
Other Study ID Numbers: 0611-55, IUCRO-0176
Study First Received: December 21, 2006
Last Updated: July 1, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Indiana University:
Storage
Bile
Biomarkers
biliary malignancies

Additional relevant MeSH terms:
Gallbladder Neoplasms
Cholangiocarcinoma
Biliary Tract Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Biliary Tract Diseases
Digestive System Diseases
Gallbladder Diseases
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on July 26, 2014