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Storage of Bile From Routine Procedures to Study Risk Factors

This study is currently recruiting participants.
Verified by Indiana University, December 2007

Sponsored by: 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

MedlinePlus related topics:   Cancer   

U.S. FDA Resources

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

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 2016

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

Responsible Party:   Indiana University ( Mary Maluccio, Principal Investigator )
Study ID Numbers:   0611-55, IUCRO-0176
First Received:   December 21, 2006
Last Updated:   December 10, 2007
ClinicalTrials.gov Identifier:   NCT00414843
Health Authority:   United States: Institutional Review Board

Keywords provided by Indiana University:
Storage  
Bile  
Biomarkers  
biliary malignancies  

Study placed in the following topic categories:
Gallbladder Diseases
Cholangiocarcinoma
Biliary Tract Neoplasms
Digestive System Neoplasms
Biliary tract cancer
Carcinoma
Gall bladder cancer
Digestive System Diseases
Biliary Tract Diseases
Gastrointestinal Neoplasms
Gallbladder Neoplasms
Adenocarcinoma
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site

ClinicalTrials.gov processed this record on September 05, 2008




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