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Outcomes in Education and Counseling for HNPCC Testing
RATIONALE: Identifying family and individual characteristics may help plan education and counseling for patients who are considering genetic testing. PURPOSE: This clinical trial is studying education and counseling to see what effect they have in patients who are undergoing genetic testing for hereditary nonpolyposis colon cancer (recruitment of new families with HNPCC stopped as of 04-26-06, recruitment of persons within families already participating continues).
OBJECTIVES: * Identify family characteristics, personality traits, and religious and spiritual beliefs that significantly affect individual decisions regarding mutation testing for hereditary nonpolyposis colon cancer (HNPCC) (recruitment of new families with HNPCC stopped as of 04-26-06, recruitment of persons within families already participating continues). * Determine the impact of negative vs positive mutation test results on family relationships and psychological status. * Assess expectations regarding testing and how they influence perceptions of risks and responses to risk notification. * Determine the impact of risk notification on the frequency of screening/prevention activities. * Formulate a standard diagnostic algorithm for determining microsatellite instability based on the analysis of tumors with this extensive array of markers and correlate specific replication error phenotypes with germline genotype. OUTLINE: Participants complete a baseline assessment of knowledge, risk perception, and personality traits followed by a structured pretest education session. Participants are then offered the choice of whether or not to undergo genetic testing for mutations in hereditary nonpolyposis colon cancer (HNPCC) genes. Participants who choose to undergo genetic testing provide a blood sample for this purpose. Participants who undergo genetic testing receive results and counseling (recruitment of new families with HNPCC stopped as of 04-26-06, recruitment of persons within families already participating continues). Available surveillance options are discussed for all participants. Psychological and behavioral outcomes are reassessed at 6 and 12 months for both those choosing and not choosing genetic testing. Tumors (when available) are analyzed for mismatched repair deficiency on the basis of microsatellite instability. PROJECTED ACCRUAL: A total of 900 participants will be accrued for this study, with a specific target of 200 individuals who have not experienced cancer within families identified with hereditary nonpolyposis colon cancer (HNPCC) mutations (recruitment of new families with HNPCC stopped as of 04-26-06, recruitment of persons within families already participating continues).
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office
Bethesda, Maryland, United States
National Human Genome Research Institute
Bethesda, Maryland, United States
Start Date
February 1, 2000
Primary Completion Date
June 1, 2011
Completion Date
June 1, 2011
Last Updated
October 24, 2014
900
ACTUAL participants
loss of heterozygosity analysis
OTHER
microsatellite instability analysis
OTHER
mutation analysis
OTHER
counseling intervention
OTHER
Lead Sponsor
National Human Genome Research Institute (NHGRI)
Collaborators
NCT04704661
NCT06696768
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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