Status:
COMPLETED
I-Scan For Colon Polyp Detection In HNPCC
Lead Sponsor:
Universitaire Ziekenhuizen KU Leuven
Conditions:
Hereditary Non-polyposis Colon Carcinoma
HNPCC
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Hereditary non-polyposis colon carcinoma (HNPCC or Lynch-Syndrome) is a rare cause of colorectal cancer caused by a gene defect in the so -called mismatch repair genes. Patients can present at young a...
Detailed Description
Hereditary non-polyposis colon carcinoma (HNPCC) or the Lynch syndrome is a rare cause of colorectal cancer caused by a defect in mismatch repair genes. Because of this, colorectal cancer does not dev...
Eligibility Criteria
Inclusion
- ≥ 18 years
- Clinical diagnosis of HNPCC according to the Amsterdam II criteria : 3 or more family members with colorectal, ovarian or endometrium cancer; 2 or more affected generations; at least one first degree relative should be affected; at least one relative with a diagnosis before the age of 50.
- Clinical diagnosis according to the modified Bethesda criteria : colon cancer before the age of 50; synchronic or metachronic colorectal of other HNPCC related tumors at any age; Colon cancer with high microsatellite instability on histology before the age of 60; Colon cancer in a patient with one or more first degree relatives with a HNPCC related tumor, and one of these being diagnosed before the age of 50; Colon cancer in a patient with 2 or more first degree relatives with HNPCC related tumors regardless the age at diagnosis
- Proven mutations in the mismatch repair genes : MLH1, MSH2, MSH6, PSM1 en PSM2
Exclusion
- History of colectomy with less than 50 cm residual colon in place
- Known colorectal tumor or polyp on referral
- Inflammatory bowel disease or primary sclerosing cholangitis
- Insufficient bowel preparation defined as a Boston Bowel preparation Scale (BBPS) of ≤ 5.
Key Trial Info
Start Date :
November 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2013
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT01823471
Start Date
November 1 2010
End Date
June 1 2013
Last Update
July 26 2017
Active Locations (1)
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1
UZ Leuven
Leuven, Belgium, 3000