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

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: Colorectal Cancer; Health Status Unknown
• Intervention / Treatment: Other: biologic sample preservation procedure; Procedure: diagnostic 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: Observational
• Enrollment (Actual): 6446

Contacts and Locations

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

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

How is the study designed?

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Vanderbilt University
• Collaborators: National Cancer Institute (NCI)
• Investigators: Study Chair: Daniel C. Liebler, PhD, Vanderbilt-Ingram Cancer Center

Study record dates

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: May 9, 2009
• First Posted (Estimate): May 12, 2009

Study Record Updates

• Last Update Posted (Actual): April 7, 2017
• Last Update Submitted That Met QC Criteria: April 5, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Keywords: colon cancer; health status unknown
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Colorectal Neoplasms; Colonic Neoplasms
• Other Study ID Numbers: CDR0000546530; P30CA068485 (U.S. NIH Grant/Contract); VU-VICC-GI-0661; VU-VICC-IRB-061096