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Outcomes in Education and Counseling for HNPCC Testing


N/A
18 Years
N/A
Open (Enrolling)
Both
Colorectal Cancer

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Trial Information

Outcomes in Education and Counseling for HNPCC Testing


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).

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Meets one of the following criteria:

- Family history consistent with hereditary nonpolyposis colon cancer (HNPCC)*

- At least 3 relatives with histologically proven colorectal cancer or
HNPCC-associated cancer and 1 is a first-degree relative of the other 2

- At least 2 successive generations affected

- Colorectal cancer (or HNPCC-associated cancer) diagnosed under age 50 in 1
of the relatives

- Diagnosis of colorectal cancer under age 41

- HNPCC-associated cancer/polyps* under age 41 with a microsatellite instability
(MSI) phenotype

- Multiple primary HNPCC-associated cancers* regardless of family history

- 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:

- Right-sided colon cancer

- Multiple primary HNPCC-associated cancers

- Diagnosis of cancer prior to age 51 NOTE: *Recruitment of new families
with HNPCC stopped as of 04-26-06, recruitment of persons within
families already participating continues

PATIENT CHARACTERISTICS:

Age:

- 18 and over

Performance status:

- Not specified

Life expectancy:

- Not specified

Hematopoietic:

- Not specified

Hepatic:

- Not specified

Renal:

- Not specified

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- Not specified

Chemotherapy:

- Not specified

Endocrine:

- Not specified

Radiotherapy:

- Not specified

Surgery:

- Not specified

Type of Study:

Interventional

Study Design:

N/A

Principal Investigator

Donald W. Hadley, MS, CGC

Investigator Role:

Study Chair

Investigator Affiliation:

National Human Genome Research Institute (NHGRI)

Authority:

Unspecified

Study ID:

CDR0000067459

NCT ID:

NCT00004210

Start Date:

February 2000

Completion Date:

Related Keywords:

  • Colorectal Cancer
  • colon cancer
  • rectal cancer
  • Colonic Neoplasms
  • Colorectal Neoplasms
  • Colorectal Neoplasms, Hereditary Nonpolyposis

Name

Location

National Human Genome Research Institute Bethesda, Maryland  20892-4470
Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office Bethesda, Maryland  20892-1182