Using mesalamine to prevent colorectal cancer in Lynch Syndrome patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial is a multicenter, multinational, randomized, double-blind phase II study that investigates the effect of 2000mg mesalamine versus placebo on colorectal neoplasia prevention in patients with Lynch Syndrome. A total of 260 tumor-free carriers of known genetic mutations in major MMR genes will be enrolled and treated for two years. Participants will undergo regular assessments, including colonoscopies, and provide blood and stool samples for further analysis of microbiota and potential biomarkers. The primary aim is to evaluate the occurrence of colorectal neoplasia and tumor progression in these patients.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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

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
* Patients with history of stage 3 and 4 CRC are excluded
* Presence of metastatic disease
* Regular use of aspirin/ASA: 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 any subtotal or total 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 IMP safety and efficacy or protocol adherence
* Prior history of myocarditis or pericarditis. Other severe acute or chronic medical condition such as severe chronic lung (COPD, including asthma, kidney and heart diseases) 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

Where it's running

• Hvidovre Hospital
  Hvidovre, Denmark Recruiting
• Sahlgrenska University Hsospital
  Gothenburg, Gothenburg, Sweden Recruiting
• Skåne University Hospital
  Malmö, Skåne County, Sweden Recruiting
• Ersta Hospital/Ersta Diakoni
  Stockholm, Sweden Recruiting
• Norrland University Hospital
  Umeå, Sweden Recruiting
• Aalborg University Hospital
  Aalborg, Denmark Not yet recruiting

Study contacts

• Principal investigator: Ann-Sofie Backman, MD PhD — Karolinska Institutet
• Study coordinator: Ann-Sofie Backman, MD PhD
• Email: ann-sofie.backman@ki.se
• Phone: 707515285

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.