Colorectal cancer (CRC) Cancer Colorectal cancer
Conditions
Interventions
Based on the results of the baseline colonoscopy, patients were assigned to different study groups (group A and B). Patients who had 3 or more adenomatous polyps at baseline were excluded and were sch
Sponsors
Leiden University Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Individuals aged between 45 and 65 years, 2. A positive family history for colorectal cancer (CRC), i.e., one first-degree relative (FDR) diagnosed with CRC <50 years, or two FDRs diagnosed with CRC at any age. Subjects were excluded if they had 3 or more adenomas at baseline colonoscopy, while those with 0-2 adenomas were randomized into two groups: A) colonoscopy at 6 years and B) colonoscopy at 3 and 6 years.
Exclusion criteria
Exclusion criteria: 1. Additional first or second-degree relatives with CRC 2. A personal history of inflammatory bowel disease 3. Previous colorectal surgery, 4. A first-degree relative with CRC with known microsatellite instability or strong suspicion of Lynch syndrome (e.g., combination of CRC and endometrial cancer).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Presence of adenoma with advanced pathology (AAP), defined as an adenoma with either high grade dysplasia, (tubulo)villous architecture or a size = 1 cm in diameter. This is measured at timepoint 6 years in group A, and at timepoints 3 and 6 years in group B. Polyps are removed during colonoscopies at these timepoints and are revised by one pathologist for characteristics of AAP. | — |
Secondary
| Measure | Time frame |
|---|---|
| Presence of adenomas. This is measured at timepoint 6 years in group A, and at timepoints 3 and 6 years in group B. Polyps are removed during colonoscopies at these timepoints and are revised by one pathologist for characteristics of adenomas. | — |
Countries
Netherlands
Outcome results
None listed