Storage of Bile From Routine Procedures to Study Risk Factors
This study is currently recruiting participants.
Verified April 2013 by Indiana University
Sponsor:
Indiana University School of Medicine
Information provided by (Responsible Party):
Indiana University ( Indiana University School of Medicine )
ClinicalTrials.gov Identifier:
NCT00414843
First received: December 21, 2006
Last updated: April 1, 2013
Last verified: April 2013
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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:
Biospecimen Retention: Samples Without DNA
Detailed 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) |
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 | 317-948-5239 | 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: | April 1, 2013 |
| 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 May 23, 2013