Mesalamine for Colorectal Cancer Prevention Program in Lynch Syndrome
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age30+
SponsorAnn-Sofie Backman
About this trial
Multicenter, multinational, randomized, 2-arm, double-blind, phase II clinical study with 2000mg mesalamine, or placebo for prevention of colorectal neoplasia in Lynch Syndrome patients during and following daily intake for 2 years.
Eligibility criteria
Qualifiers
Proven tumor-free (including patients in which the polyps are removed endoscopically) carriers of a germline pathologic mutation in one of the MMR genes including MLH1, MSH2 (including EpCAM) and MSH6
Male or female subjects with the age of 30 years or older
Females who have been post-menopausal more than one (1) year or females of childbearing potential using a highly efficient method of contraception with less than 1% failure rate (i.e. oral hormonal contraceptives, hormone implants, hormone injections, sterilization, hormonal or copper intrauterine device, sterilized/vasectomized partner, or diaphragm in combination with a condom, spermicide or birth control pills) or should agree to abstain from heterosexual activity during treatment period. Females of childbearing potential must have a negative pregnancy test at screening and before randomization.
Signed written informed consent prior to inclusion in the study
Disqualifiers
Presence of colorectal 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
Trial design
Treatments tested in this trial
- Mesalamine
- Placebo
Treatment groups
150 Participants
are divided into 2 treatment groupsSponsors and collaborators
Ann-Sofie Backman
Lead sponsor
Karolinska University Hospital
Sponsor institution
The Swedish Research Council
Collaborator
Karolinska Institutet
Collaborator
Source ClinicalTrials.gov