NCT00414843

Brief Summary

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
390

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2006

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2006

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

December 21, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 22, 2006

Completed
8.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2015

Completed
Last Updated

February 23, 2016

Status Verified

February 1, 2016

Enrollment Period

8.7 years

First QC Date

December 21, 2006

Last Update Submit

February 22, 2016

Conditions

Gallbladder CancerCholangiocarcinomaBiliary Tract Cancer

Keywords

StorageBileBiomarkersbiliary malignancies

Outcome Measures

Primary Outcomes (1)

  • Establish Repository of Human Bile

    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.

    2024

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Subjects presenting to Indiana University for treatment of biliary tract disease.

You may qualify if:

  • Presenting to IU for treatment of biliary tract disease; Age greater than or equal to 18

You may not qualify if:

  • Problems other than biliary tract disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Indiana University Hospital

Indianapolis, Indiana, 46202, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Bile, plasma

MeSH Terms

Conditions

Gallbladder NeoplasmsCholangiocarcinomaBiliary Tract Neoplasms

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsBiliary Tract DiseasesDigestive System DiseasesGallbladder DiseasesAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic Type

Study Officials

  • Mary Maluccio, MD

    Indiana University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 21, 2006

First Posted

December 22, 2006

Study Start

December 1, 2006

Primary Completion

August 1, 2015

Study Completion

August 1, 2015

Last Updated

February 23, 2016

Record last verified: 2016-02

Locations

US(1)