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Genetic and Environmental Risk Assessment for Colorectal Cancer in Healthy Participants
This study has been completed.
Sponsors and Collaborators: Fox Chase Cancer Center
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00087360
  Purpose

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
 Procedure: counseling
Procedure: evaluation of cancer risk factors
Procedure: physiologic testing

MedlinePlus related topics: Cancer Colorectal Cancer
U.S. FDA Resources
Study Type: Interventional
Study Design: Screening
Official Title: Providing Genetic And Environmental Cancer Risk Assessment In Primary Care

Further study details as provided by National Cancer Institute (NCI):

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
Detailed Description:

OBJECTIVES:

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.

  Eligibility

Ages Eligible for Study:   50 Years to 74 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

DISEASE CHARACTERISTICS:

  • 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

PATIENT CHARACTERISTICS:

Age

  • 50 to 74

Performance status

  • Not specified

Life expectancy

  • Not specified

Hematopoietic

  • Not specified

Hepatic

  • Not specified

Renal

  • Not specified

Other

  • 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)

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • Not specified

Chemotherapy

  • Not specified

Endocrine therapy

  • Not specified

Radiotherapy

  • Not specified

Surgery

  • Not specified
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00087360

Locations
United States, Maryland
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
Bethesda, Maryland, United States, 20892-1182
United States, Pennsylvania
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States, 19111
Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
Philadelphia, Pennsylvania, United States, 19107-5541
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)
Investigators
Study Chair: David Weinberg, MD, MSC Fox Chase Cancer Center
  More Information

Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

Study ID Numbers: CDR0000374972, FCCC-03030
Study First Received: July 8, 2004
Last Updated: October 12, 2008
ClinicalTrials.gov Identifier: NCT00087360  
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
colon cancer
rectal cancer

Study placed in the following topic categories:
Digestive System Neoplasms
Rectal Neoplasms
Gastrointestinal Diseases
Colonic Diseases
Healthy
Intestinal Diseases
Rectal Diseases
 Intestinal Neoplasms
Rectal neoplasm
Digestive System Diseases
Gastrointestinal Neoplasms
Rectal cancer
Colorectal Neoplasms

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on January 15, 2009



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