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Genetic and Environmental Risk Assessment for Colorectal Cancer in Healthy Participants

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00087360
Recruitment Status : Completed
First Posted : July 12, 2004
Last Update Posted : July 11, 2013
Information provided by (Responsible Party):

Study Description
Brief Summary:

RATIONALE: Evaluating the knowledge and attitudes of healthy participants toward a new diet and gene test for colorectal cancer risk may help doctors improve acceptance of colorectal cancer screening.

PURPOSE: This clinical trial is studying the knowledge and attitudes of healthy participants toward genetic and environmental risk assessment for colorectal cancer.

Condition or disease Intervention/treatment
Colorectal Cancer Other: counseling intervention Other: physiologic testing Procedure: evaluation of cancer risk factors

Detailed Description:


Part 1

  • Determine the willingness of healthy participants to enroll in a genetic and environmental risk assessment for colorectal cancer.
  • Determine the impact of decision counseling on knowledge and attitudes about genetic and environmental risk assessment (GERA) and colorectal cancer screening in these participants.
  • Determine participants' understanding of GERA.
  • Determine participants' response to GERA results.

Part 2

  • Determine awareness of, and interest in, diet and genetic assessment for colorectal cancer among healthy participants at average risk for colorectal cancer who have not undergone regular colon cancer screening.
  • Determine participants' level of knowledge of this assessment.
  • Determine participants' rate of acceptance into this study.

OUTLINE: This is a 2-part pilot study.

  • Part 1: Participants complete a baseline questionnaire on attitudes, beliefs, and knowledge about colorectal cancer (CRC), CRC screening, and diet and genetic testing for colorectal cancer risk. Two-four weeks later, participants are educated about CRC screening options and undergo genetic and environmental risk assessment (GERA) decision counseling about the methylene tetrahydrofolate reductase (MTHFR) gene and dietary folate intake. Participants who decide to undergo GERA undergo blood testing for MTHFR polymorphisms and folate levels. Participants whose blood tests indicate low folate levels are further counseled about dietary folate intake.
  • Part 2: Participants complete a questionnaire on attitudes, beliefs, and knowledge about CRC, CRC screening, and diet and genetic testing for colorectal cancer risk.

Participants in part 1 are followed at 1 week, 1 month, and then at 6 months.

PROJECTED ACCRUAL: A total of 110 participants (60 for part 1 and 50 for part 2) will be accrued for this study.

Study Design

Study Type : Interventional  (Clinical Trial)
Primary Purpose: Screening
Official Title: Providing Genetic And Environmental Cancer Risk Assessment In Primary Care
Study Start Date : November 2003
Primary Completion Date : May 2007
Study Completion Date : May 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Outcome Measures

Primary Outcome Measures :
  1. Colorectal cancer (CRC) screening rates by chart review at 4 months

Secondary Outcome Measures :
  1. Knowledge regarding CRC risk by questionnaires at 4 and 12 months
  2. CRC risk perception by questionnaires at 4 and 12 months

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 74 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes


  • Healthy participants
  • Eligible for colorectal cancer screening
  • No personal or family history of colorectal cancer

    • No more than 1 first-degree relative who has had colorectal cancer
  • Part 1:

    • Has not undergone regular screening for colorectal cancer
  • Part 2:

    • Not currently undergoing regular colon cancer testing, including any of the following:

      • Fecal occult blood testing within the past year
      • Flexible sigmoidoscopy or colonoscopy within the past 5 years



  • 50 to 74

Performance status

  • Not specified

Life expectancy

  • Not specified


  • Not specified


  • Not specified


  • Not specified


  • No inflammatory bowel disease (part 1 only)
  • No concurrent health issues that would preclude study participation (part 1 only)
  • No history of cancer except basal cell or squamous cell skin cancer (part 2 only)
  • Able to speak and read English (part 2 only)


Biologic therapy

  • Not specified


  • Not specified

Endocrine therapy

  • Not specified


  • Not specified


  • Not specified
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00087360

United States, Maryland
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
Bethesda, Maryland, United States, 20892-1182
United States, Pennsylvania
Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
Philadelphia, Pennsylvania, United States, 19107-5541
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States, 19111
United States, Tennessee
Vanderbilt-Ingram Cancer Center at Vanderbilt Medical Center
Nashville, Tennessee, United States, 37232-0165
Sponsors and Collaborators
Fox Chase Cancer Center
National Cancer Institute (NCI)
Study Chair: David Weinberg, MD, MSC Fox Chase Cancer Center
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Fox Chase Cancer Center
ClinicalTrials.gov Identifier: NCT00087360     History of Changes
Other Study ID Numbers: FCCC-03030
CDR0000374972 ( Registry Identifier: PDQ (Physician Data Query) )
First Posted: July 12, 2004    Key Record Dates
Last Update Posted: July 11, 2013
Last Verified: July 2013

Keywords provided by Fox Chase Cancer Center:
colon cancer
rectal cancer

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