Genetic and Environmental Risk Assessment for Colorectal Cancer in Healthy Participants

This study has been completed.
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Fox Chase Cancer Center Identifier:
First received: July 8, 2004
Last updated: July 10, 2013
Last verified: July 2013

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 Intervention
Colorectal Cancer
Other: counseling intervention
Other: physiologic testing
Procedure: evaluation of cancer risk factors

Study Type: Interventional
Study Design: Primary Purpose: Screening
Official Title: Providing Genetic And Environmental Cancer Risk Assessment In Primary Care

Resource links provided by NLM:

Further study details as provided by Fox Chase Cancer Center:

Primary Outcome Measures:
  • Colorectal cancer (CRC) screening rates by chart review at 4 months [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Knowledge regarding CRC risk by questionnaires at 4 and 12 months [ Designated as safety issue: No ]
  • CRC risk perception by questionnaires at 4 and 12 months [ Designated as safety issue: No ]

Study Start Date: November 2003
Study Completion Date: May 2007
Primary Completion Date: May 2007 (Final data collection date for primary outcome measure)
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.


Ages Eligible for Study:   50 Years to 74 Years
Genders Eligible for Study:   Both
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
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 identifier: 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

Responsible Party: Fox Chase Cancer Center Identifier: NCT00087360     History of Changes
Other Study ID Numbers: FCCC-03030  CDR0000374972 
Study First Received: July 8, 2004
Last Updated: July 10, 2013
Health Authority: United States: Federal Government

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

Additional relevant MeSH terms:
Colorectal Neoplasms
Colonic Diseases
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Intestinal Diseases
Intestinal Neoplasms
Neoplasms by Site
Rectal Diseases processed this record on May 04, 2016