Blood and Tissue Sample Collection for Future Colon Cancer Biomarker Studies in Patients Undergoing Colonoscopy

The recruitment status of this study is unknown because the information has not been verified recently.

Verified October 2008 by National Cancer Institute (NCI).
Recruitment status was Recruiting

Sponsor:

Collaborator:

National Cancer Institute (NCI)

Information provided by:

National Cancer Institute (NCI)

ClinicalTrials.gov Identifier:

NCT00897403

First received: May 9, 2009

Last updated: August 11, 2009

Last verified: October 2008

History of Changes

Tracking Information

First Received Date ^ICMJE

May 9, 2009

Last Updated Date

August 11, 2009

Start Date ^ICMJE

February 2007

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Collection of blood and tissue [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00897403 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Current Other Outcome Measures ^ICMJE

Original Other Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Blood and Tissue Sample Collection for Future Colon Cancer Biomarker Studies in Patients Undergoing Colonoscopy

Official Title ^ICMJE

Discovery of Candidate Biomarkers in Colon Cancer and Precancers Repository

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.

Detailed Description

OBJECTIVES:

Collect blood and tissue samples (including polyps, abnormal growths, cancer, and normal tissue) from patients undergoing colonoscopy.

OUTLINE: Patients undergo blood and tissue sample collection during colonoscopy. Samples are stored for future biomarker proteomic profiling.

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Biospecimen

Sampling Method

Study Population

Condition ^ICMJE

Colorectal Cancer
Health Status Unknown

Intervention ^ICMJE

Other: biologic sample preservation procedure
Procedure: diagnostic colonoscopy

Study Group/Cohort (s)

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

3000

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

25 Years to 75 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00897403

Other Study ID Numbers ^ICMJE

CDR0000546530, VU-VICC-GI-0661, VU-VICC-IRB-061096

Has Data Monitoring Committee

Responsible Party

Study Sponsor ^ICMJE

Vanderbilt-Ingram Cancer Center

Collaborators ^ICMJE

National Cancer Institute (NCI)

Investigators ^ICMJE

Study Chair:

Daniel C. Liebler, PhD

Vanderbilt-Ingram Cancer Center

Information Provided By

National Cancer Institute (NCI)

Verification Date

October 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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