hereditary colon cancer Lynch syndrome
Conditions
Interventions
screening visit: laboratory examinations (hematology, serum chemistry,
creatinine, amylase and lipase), pregnancy test, colonoscopy, (colonoscopy is
standard test) serum and stool. Total amount of b
colorectal cancer
Lynch syndrome
mesalamine
Sponsors
Medical University of Vienna
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: * Proven tumor-free (including patients in which the polyps are removed endoscopically) carriers of a germline pathologic mutation on one of the MMR genes including MLH1, MSH2 (including EpCAM) en MSH6. * Male or female subjects with the age > 30 years * Signed written informed consent prior to inclusion in the study
Exclusion criteria
Exclusion criteria: * Presence of colonic endoscopically non-removable benign neoplasia (patient can be included if the adenoma is removed) * Carriers of germline mutations in PMS2. * Patients with history of stage 3 and 4 CRC are excluded * Presence of metastatic disease * Regular use of aspirin: daily use of *100mg in more than 3 continuous months within the last year * Regular use of NSAIDs or COX-2 inhibitors: daily use in more than 3 continuous months within the last year * Hypersensitivity to 5-ASA * Patients after total or subtotal colectomy * Colorectal surgery within the previous 6 months * Unwillingness to participate or who is considered incompetent to give an informed consent * Pregnant or breastfeeding women * Participation in another clinical study investigating another IMP within 1 month prior to screening * Renal insufficiency (GFR
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The occurrence of neoplasms will be described by absolute frequencies and percentages together with 95 % confidence intervals. A logistic regression is used to assess differences between active treatment and placebo for the occurrence of neoplasms, adjusted for country and history of cancer before randomization. Treatment effects are assessed by odds-ratios and corresponding 95 % confidence intervals. | — |
Secondary
| Measure | Time frame |
|---|---|
| The number of neoplasms per patient will be tested between groups by an analysis of variance, adjusting for country and history of cancer before randomization. In case of non-normally distributed residuals a suitable transformation to achieve normal distribution or a Poisson regression model is considered , whatever achieves a better model fit. The tumor progress in the 4 ordered stages will be tested between groups by a chi-square trend test stratified for country and and history of cancer before randomization. Additionally ordinal logistic regression will be applied in analyogy to the analysis of the primary endpoint. The same methods are used to assess differences between low and high dose 5-ASA on the occurrence of neoplasms, the number of neoplasms and tumor progression. Additionally interactions of CRC history, gender and patients age ( | — |
Countries
Austria, Germany, Israel, Netherlands, Poland, Sweden
Outcome results
None listed