Using mesalamine to prevent colorectal cancer in Lynch Syndrome patients
Mesalamine for Colorectal Cancer Prevention Program in Lynch Syndrome
This study is testing if taking mesalamine can help prevent colorectal cancer in people with Lynch Syndrome.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Ages | 30 Years and up |
| Sex | All |
| Sponsor | Karolinska University Hospital Academic / other |
| Locations | 8 sites (Aalborg and 7 other locations) |
| Trial ID | NCT04920149 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are tumor-free individuals aged 30 and older with a known germline mutation in MMR genes.
Not a fit: Patients with existing colorectal cancer or those not meeting the genetic mutation criteria may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly reduce the risk of colorectal cancer in patients with Lynch Syndrome.
How similar studies have performed: While similar studies have explored preventive measures in Lynch Syndrome, the specific use of mesalamine for this purpose is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Aalborg and 7 other locations
- Aalborg University Hospital — Aalborg, Denmark (Not_yet_recruiting)
- 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)
- Karolinska University Hospital — Stockholm, Sweden (Active_not_recruiting)
- Norrland University Hospital — Umeå, Sweden (Recruiting)
- Akademiska hospital — Uppsala, Sweden (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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.