Mesalamine for Colorectal Cancer Prevention Program in Lynch syndrome

Recruitment & Eligibility

Status: Withdrawn

Sex: Not specified

Target Recruitment: 170

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

* 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 <30ml/min/1.73m²)
* Severe liver disease or liver failure (elevation of liver enzymes above 3xULN)
* Current or history of serious psychiatric disorder or alcohol/drug abuse that in the opinion of
the investigator may impact the assessment of safety, efficacy or protocol adherence.
* Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that
may increase the risk associated with study participation or ability to comply with study
procedures, investigational product administration and, in the judgment of the investigator,
would make the subject inappropriate for entry into this study.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The occurrence of neoplasms will be described by absolute frequencies<br /><br>and percentages together with 95 % confidence intervals. A logistic<br /><br>regression is used to assess differences between active treatment and<br /><br>placebo for the occurrence of neoplasms, adjusted for country and history of<br /><br>cancer before randomization. Treatment effects are assessed by<br /><br>odds-ratios and corresponding 95 % confidence intervals.</p><br>

Secondary Outcome Measures