NCT00897403

Brief Summary

RATIONALE: Collecting and storing samples of blood and tissue from patients undergoing colonoscopy to study in the laboratory may help doctors learn more about colon cancer and identify biomarkers related to colon cancer in the future. PURPOSE: This laboratory study is collecting blood and tissue samples for future colon cancer biomarker studies in patients undergoing colonoscopy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
6,446

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2006

Longer than P75 for all trials

Geographic Reach
1 country

4 active sites

Status
completed

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
2.4 years until next milestone

First Submitted

Initial submission to the registry

May 9, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 12, 2009

Completed
6.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2016

Completed
Last Updated

April 7, 2017

Status Verified

April 1, 2017

Enrollment Period

8.7 years

First QC Date

May 9, 2009

Last Update Submit

April 5, 2017

Conditions

Colorectal CancerHealth Status Unknown

Keywords

colon cancerhealth status unknown

Outcome Measures

Primary Outcomes (1)

  • Collection of blood and tissue

    Pre-op & during surgery

Interventions

biologic sample preservation procedureOTHER
diagnostic colonoscopyPROCEDURE

Eligibility Criteria

Age25 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients scheduled for colonoscopy either as routine screening or for a specific problem.

DISEASE CHARACTERISTICS: * Scheduled for colonoscopy as routine screening or for a specific problem PATIENT CHARACTERISTICS: * Not pregnant PRIOR CONCURRENT THERAPY: * No concurrent participation in a clinical trial to treat cancer or prevent cancer recurrence

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (4)

Vanderbilt-Ingram Cancer Center - Cool Springs

Nashville, Tennessee, 37064, United States

Location

Vanderbilt-Ingram Cancer Center at Franklin

Nashville, Tennessee, 37064, United States

Location

Dan Rudy Cancer Center at Saint Thomas Hospital

Nashville, Tennessee, 37205, United States

Location

Vanderbilt-Ingram Cancer Center

Nashville, Tennessee, 37232-6838, United States

Location

MeSH Terms

Conditions

Colorectal NeoplasmsColonic Neoplasms

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Study Officials

  • Daniel C. Liebler, PhD

    Vanderbilt-Ingram Cancer Center

    STUDY CHAIR

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Adjunct Professor

Study Record Dates

First Submitted

May 9, 2009

First Posted

May 12, 2009

Study Start

December 1, 2006

Primary Completion

August 1, 2015

Study Completion

April 1, 2016

Last Updated

April 7, 2017

Record last verified: 2017-04

Locations

US(4)