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

April 5, 2017 updated by: Daniel Liebler, Vanderbilt University

Discovery of Candidate Biomarkers in Colon Cancer and Precancers Repository

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Observational

Enrollment (Actual)

6446

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

United States
- Tennessee
  - Nashville, Tennessee, United States, 37232-6838
    - Vanderbilt-Ingram Cancer Center
  - Nashville, Tennessee, United States, 37064
    - Vanderbilt-Ingram Cancer Center - Cool Springs
  - Nashville, Tennessee, United States, 37064
    - Vanderbilt-Ingram Cancer Center at Franklin
  - Nashville, Tennessee, United States, 37205
    - Dan Rudy Cancer Center at Saint Thomas Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Collection of blood and tissue Time Frame: Pre-op & during surgery	Pre-op & during surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vanderbilt University

Collaborators

National Cancer Institute (NCI)

Investigators

Study Chair: Daniel C. Liebler, PhD, Vanderbilt-Ingram Cancer Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2006

Primary Completion (Actual)

August 1, 2015

Study Completion (Actual)

April 1, 2016

Study Registration Dates

First Submitted

May 9, 2009

First Submitted That Met QC Criteria