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Sponsors and Collaborators: |
National Human Genome Research Institute (NHGRI) National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00004210 |
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).
Condition | Intervention |
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Colorectal Cancer |
Genetic: loss of heterozygosity analysis Genetic: microsatellite instability analysis Genetic: mutation analysis Other: counseling intervention |
Study Type: | Interventional |
Official Title: | Outcomes in Education and Counseling for HNPCC Testing |
Estimated Enrollment: | 900 |
Study Start Date: | February 2000 |
OBJECTIVES:
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).
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Meets one of the following criteria:
Family history consistent with hereditary nonpolyposis colon cancer (HNPCC)*
Colorectal or other HNPCC-associated tumor/polyp* demonstrating a positive MSI phenotype and at least 1 second-degree (or closer) and 1 third-degree (or closer) relative with a HNPCC-associated cancer
1 affected family member must have one of the following:
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine:
Radiotherapy:
Surgery:
United States, Maryland | |
National Human Genome Research Institute | Recruiting |
Bethesda, Maryland, United States, 20892-4470 | |
Contact: Clinical Trials Office - National Human Genome Research Instit 301-402-8255 | |
Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office | Recruiting |
Bethesda, Maryland, United States, 20892-1182 | |
Contact: Clinical Trials Office - Warren Grant Magnusen Clinical Center 888-NCI-1937 |
Study Chair: | Donald W. Hadley, MS | National Human Genome Research Institute (NHGRI) |
Study ID Numbers: | CDR0000067459, NCI-95-HG-0165, NCI-NMOB-9501, NHGRI-95-HG-0165 |
Study First Received: | January 21, 2000 |
Last Updated: | March 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00004210 History of Changes |
Health Authority: | Unspecified |
colon cancer rectal cancer |
Metabolic Diseases Digestive System Neoplasms Rectal Neoplasms Gastrointestinal Diseases Colonic Diseases Rectal Neoplasm Intestinal Diseases Rectal Diseases Intestinal Neoplasms |
Rectal Cancer Digestive System Diseases Neoplastic Syndromes, Hereditary Colorectal Neoplasms, Hereditary Nonpolyposis Genetic Diseases, Inborn Hereditary Nonpolyposis Colon Cancer Gastrointestinal Neoplasms Metabolic Disorder Colorectal Neoplasms |
Metabolic Diseases Digestive System Neoplasms Gastrointestinal Diseases DNA Repair-Deficiency Disorders Colonic Diseases Intestinal Diseases Rectal Diseases Intestinal Neoplasms |
Neoplasms Neoplasms by Site Digestive System Diseases Neoplastic Syndromes, Hereditary Genetic Diseases, Inborn Colorectal Neoplasms, Hereditary Nonpolyposis Gastrointestinal Neoplasms Colorectal Neoplasms |