Mesalamine administration to prevent development of colorectal cancer in Lynch syndrome.

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 360

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) and MSH6.
- Male or female subjects with the age > 30 years.
- Females who have been post-menopausal more than one (1) year or females of childbearing potential using a highly efficient method of contraception.
- Signed written informed consent.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 300
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 60

Exclusion Criteria

- Presence of colorectal endoscopically non-removable benign neoplasia (patient can be included if the adenoma is removed).
- Carriers of germline mutations in PMS2.
- History of stage 3 and 4 colorectal cancer (CRC).
- Presence of any metastatic disease.
- Regular use of acetylsalicylic acid (ASA or 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.
- Subtotal or total colectomy.
- Colorectal surgery within the previous 6 months.
- Unwillingness to participate or considered unable to give an informed consent.
- Pregnancy or ongoing breastfeeding.
- Participation in another clinical study investigating another IMP within 3 months 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 IMP safety and efficacy or protocol adherence
- History of myocarditis or pericarditis. Other severe acute or chronic medical condition (such as severe chronic lung (COPD, including asthma), kidney or heart diseases) or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or ability to comply with study procedures, IMP administration and, in the judgment of the investigator, would make the subject inappropriate for entry into this study