Clinical trial · Observational
Attitudes Towards Prophylactic Colectomy in Hereditary Non-polyposis Colorectal Cancer (HNPCC) Patients
Attitudes Towards Prophylactic Colectomy in HNPCC Patients
NCT00582452CI-TRIAL-00002876completedClinicalTrials.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)
The purpose of this study is to learn more about individual's with a family history of colon cancer and the process by which they may decide to undergo or not undergo prophylactic colectomy. This is a surgery to remove the colon in order to reduce risk of cancer (or of getting cancer again).
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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Telephone survey | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- 2
- description
- Affected patients who are at high risk for metachronous colorectal tumors due to mutation status.
- interventionNames
- Other: Telephone survey
- label
- 1
- description
- Unaffected patients who are at high risk for developing colon cancer based on family history and/or mutation status.
- interventionNames
- Other: Telephone survey
Primary outcomes (1)
- measure
- To assess levels of intention in prophylactic colectomy among individuals at increased familial risk of colorectal cancer and to identify distinctive decision types based on profiles of perceived pros and cons of prophylactic colectomy;
- timeFrame
- 12 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * are from a family that has a known mismatch repair mutation; or * meet Amsterdam I or Amsterdam II criteria that spell out the family and personal cancer history characteristics associated with HNPCC * are considered at sufficiently high risk by their CRC specialty physician that prophylactic colectomy may be presented as an option (excluding FAP). Amsterdam I Criteria 1. At least three relatives with a colorectal cancer and the following criteria: * One should be a first degree relative of the other two * At least two successive generations should be affected * At least one colorectal cancer should be diagnosed before the age of 50 * Familial Adenomatous Polyposis (FAP) should be excluded in the colorectal cancer case(s), if any Amsterdam II Criteria (also known as Revised Amsterdam Criteria 2. At least three relatives with an HNPCC-associated cancer (colorectal cancer, cancer of the endometrium, small bowel, ureter, or renal pelvis) \*: * One should be a first degree relative of the other two * At least two successive generations should be affected * At least one relative should be diagnosed before age 50 * FAP should be excluded in the colorectal cancer case(s), if any \*NOTE: ovarian cancer will also be considered an HNPCCassociated cancer as per Lynch et al (NEJM 2003) Exclusion Criteria: * non-English speaking * under the age of 18 * are unable to give meaningful informed consent due to physical, psychiatric or cognitive disability * are from a family affected by FAP * have already undergone subtotal colectomy or total proctocolectomy * are in active treatment and/or less than six months post-surgery for cancer. * Have undergone genetic counseling and testing for HNPCC at MSKCC
References
Publications (0)
Data not yet available
No reference posted for this study.