Study of the Results of Education and Counseling for Persons Undergoing Genetic Testing for Hereditary Nonpolyposis Colon Cancer

NCT00004210 | Completed

• 4 other identifiers: CDR0000067459NCI-95-HG-0165NCI-NMOB-9501NHGRI-95-HG-0165
• Study Type: interventional
• Target: 900
• Locations: 1 country
• Sites: 2

Brief Summary

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).

Conditions

Colorectal Cancer

Keywords

colon cancer; rectal cancer

Outcome Measures

Primary Outcomes (1)

• Assessment of cancer risk perception, cancer screening practices, views regarding genetic services, and family communication about HNPCC / Lynch syndrome by family members

Interventions

loss of heterozygosity analysis OTHER

microsatellite instability analysis OTHER

mutation analysis OTHER

counseling intervention OTHER

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• National Human Genome Research Institute (NHGRI): lead
• National Cancer Institute (NCI): collaborator

Study Sites (2)

Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office

Bethesda, Maryland, 20892-1182, United States

Location

National Human Genome Research Institute

Bethesda, Maryland, 20892-4470, United States

Location

Related Publications (4)

• Hadley DW, Ashida S, Jenkins JF, Calzone KA, Kirsch IR, Koehly LM. Colonoscopy use following mutation detection in Lynch syndrome: exploring a role for cancer screening in adaptation. Clin Genet. 2011 Apr;79(4):321-8. doi: 10.1111/j.1399-0004.2010.01622.x. Epub 2011 Jan 19.

  PMID: 21204803 RESULT

• Hadley DW, Jenkins JF, Dimond E, de Carvalho M, Kirsch I, Palmer CG. Colon cancer screening practices after genetic counseling and testing for hereditary nonpolyposis colorectal cancer. J Clin Oncol. 2004 Jan 1;22(1):39-44. doi: 10.1200/JCO.2004.06.128.

  PMID: 14701766 RESULT

• Hadley DW, Jenkins J, Dimond E, Nakahara K, Grogan L, Liewehr DJ, Steinberg SM, Kirsch I. Genetic counseling and testing in families with hereditary nonpolyposis colorectal cancer. Arch Intern Med. 2003 Mar 10;163(5):573-82. doi: 10.1001/archinte.163.5.573.

  PMID: 12622604 RESULT

• Hadley DW, Eliezer D, Addissie Y, Goergen A, Ashida S, Koehly L. Uptake and predictors of colonoscopy use in family members not participating in cascade genetic testing for Lynch syndrome. Sci Rep. 2020 Sep 29;10(1):15959. doi: 10.1038/s41598-020-72938-z.

  PMID: 32994442 DERIVED

MeSH Terms

Conditions

Colorectal Neoplasms; Colonic Neoplasms; Rectal Neoplasms

Interventions

Counseling

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Mental Health Services; Behavioral Disciplines and Activities; Community Health Services; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Donald W. Hadley, MS, CGC

  National Human Genome Research Institute (NHGRI)

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 21, 2000
• First Posted: January 27, 2003
• Study Start: February 1, 2000
• Primary Completion: June 1, 2011
• Study Completion: June 1, 2011
• Last Updated: October 24, 2014

Record last verified: 2009-07

Locations

US (2)