Clinical trial · Interventional
Study of the Results of Education and Counseling for Persons Undergoing Genetic Testing for Hereditary Nonpolyposis Colon Cancer
Outcomes in Education and Counseling for HNPCC Testing
NCT00004210CI-TRIAL-00015903completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| counseling intervention | Other | — | UNRESOLVED |
| loss of heterozygosity analysis | Other | — | UNRESOLVED |
| microsatellite instability analysis | Other | — | UNRESOLVED |
| mutation analysis | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Assessment of cancer risk perception, cancer screening practices, views regarding genetic services, and family communication about HNPCC / Lynch syndrome by family members
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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 specifiedReferences
Publications (4)
- RESULTHadley 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
- RESULTHadley 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
- RESULTHadley 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
- DERIVEDHadley 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