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NCT00897403 Clinical Trial

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

Colorectal Cancer Clinical Trial

Official title:
Discovery of Candidate Biomarkers in Colon Cancer and Precancers Repository

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00897403
Other study ID # CDR0000546530
Secondary ID P30CA068485VU-VI
Status Completed
Phase N/A
First received May 9, 2009
Last updated April 5, 2017
Start date December 2006
Est. completion date April 2016

Study information
Verified date April 2017
Source Vanderbilt University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 6446
Est. completion date April 2016
Est. primary completion date August 2015
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 25 Years to 75 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• biologic sample preservation procedure

Procedure:
• diagnostic colonoscopy

Locations
Country Name City State
United States Dan Rudy Cancer Center at Saint Thomas Hospital Nashville Tennessee
United States Vanderbilt-Ingram Cancer Center Nashville Tennessee
United States Vanderbilt-Ingram Cancer Center - Cool Springs Nashville Tennessee
United States Vanderbilt-Ingram Cancer Center at Franklin Nashville Tennessee

Sponsors (2)
Lead Sponsor Collaborator
Vanderbilt University National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Collection of blood and tissue Pre-op & during surgery
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