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

This study has been completed.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Daniel Liebler, Vanderbilt University Medical Center
ClinicalTrials.gov Identifier:
NCT00897403
First received: May 9, 2009
Last updated: April 5, 2017
Last verified: April 2017
  Purpose

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.


Condition Intervention
Colorectal Cancer
Health Status Unknown
Other: biologic sample preservation procedure
Procedure: diagnostic colonoscopy

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Discovery of Candidate Biomarkers in Colon Cancer and Precancers Repository

Resource links provided by NLM:


Further study details as provided by Vanderbilt University:

Primary Outcome Measures:
  • Collection of blood and tissue [ Time Frame: Pre-op & during surgery ]

Enrollment: 6446
Actual Study Start Date: December 2006
Study Completion Date: April 2016
Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   25 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Patients scheduled for colonoscopy either as routine screening or for a specific problem.
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00897403

Locations
United States, Tennessee
Vanderbilt-Ingram Cancer Center - Cool Springs
Nashville, Tennessee, United States, 37064
Vanderbilt-Ingram Cancer Center at Franklin
Nashville, Tennessee, United States, 37064
Dan Rudy Cancer Center at Saint Thomas Hospital
Nashville, Tennessee, United States, 37205
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States, 37232-6838
Sponsors and Collaborators
Vanderbilt University
National Cancer Institute (NCI)
Investigators
Study Chair: Daniel C. Liebler, PhD Vanderbilt-Ingram Cancer Center
  More Information

Responsible Party: Daniel Liebler, Adjunct Professor, Vanderbilt University Medical Center
ClinicalTrials.gov Identifier: NCT00897403     History of Changes
Other Study ID Numbers: CDR0000546530
P30CA068485 ( US NIH Grant/Contract Award Number )
VU-VICC-GI-0661
VU-VICC-IRB-061096
Study First Received: May 9, 2009
Last Updated: April 5, 2017

Keywords provided by Vanderbilt University:
colon cancer
health status unknown

Additional relevant MeSH terms:
Colorectal Neoplasms
Colonic Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases

ClinicalTrials.gov processed this record on April 28, 2017