Attitudes Towards Prophylactic Colectomy in Hereditary Non-polyposis Colorectal Cancer (HNPCC) Patients

Completed

Conditions studied: Colorectal Cancer

In brief

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).

Key facts

Study ID

NCT00582452

Run by

Memorial Sloan Kettering Cancer Center

People needed

16

Starts

2004-11-01

Expected to finish

2009-12-01

Last updated by the study team

2009-12-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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
• 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
• 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)

You may not qualify if…

• 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

Where it is running

• Memorial Sloan Kettering Cancer Center — New York, New York, United States

Full record on ClinicalTrials.gov

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