Testing mesalamine to help prevent colon cancer in people with Lynch syndrome
Tests mesalamine against a placebo in adults with Lynch syndrome.
Plain-language title generated from the registry record
Registry title: Mesalamine for Colorectal Cancer Prevention Program in Lynch Syndrome
Key facts
- Where
- Aalborg and Hvidovre, DenmarkSee the 2 sites
- Phase
- Phase 2
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults aged 30 or older who carry a Lynch syndrome gene change and have no tumour. It tests mesalamine or placebo for 2 years to prevent bowel neoplasia.
- Age
- 30 years or older
- Sex
- Women and men can join.
- Disease stage
- Carriers of a Lynch syndrome gene change who are tumour-free. Polyps that were removed endoscopically are allowed.
- Earlier treatment
- Cannot join if you regularly used aspirin/ASA (daily ≥100mg for more than 3 continuous months in the last year) or NSAIDs or COX-2 inhibitors (daily for more than 3 continuous months in the last year). Cannot join after a subtotal or total colectomy or colorectal surgery in the last 6 months.
- Biomarker or test result
- A proven germline harmful change in one of the MMR genes: MLH1, MSH2 (including EpCAM) or MSH6.
Main reasons for not taking part
- Carriers of a germline change in PMS2
- Past stage 3 or 4 colorectal cancer, or metastatic disease
- Colorectal growths that cannot be removed endoscopically
- Hypersensitivity to 5-ASA, or kidney insufficiency (GFR <30ml/min/1.73m2)
- Pregnant or breastfeeding women
Read by machine on 9 November 2026.
Where in Denmark
- Aalborg University HospitalAalborg, DenmarkNo longer taking part
- Hvidovre HospitalHvidovre, DenmarkNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Ann-Sofie Backman
- Trial code
- NCT04920149EU 2024-514765-19-01
- Record updated
- 17 December 2024
- Original description
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.Read full original descriptionShow less
Mesalamine for Colorectal Cancer Prevention Program in Lynch Syndrome
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.
Inclusion: 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: Regular use of NSAIDs or COX-2 inhibitors: daily use in more than 3 continuous months within the last year; Colorectal surgery within the previous 6 months; Participation in another clinical study investigating another IMP within 1 month prior to screening; Patients with history of stage 3 and 4 CRC are excluded; Presence of metastatic disease; Hypersensitivity to 5-ASA; 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; Renal insufficiency (GFR <30ml/min/1.73m2); 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; Presence of colorectal endoscopically non-removable benign neoplasia (patient can be included if the adenoma is removed); Carriers of germline mutations in PMS2; Regular use of aspirin/ASA: daily use of ≥100mg in more than 3 continuous months within the last year; Patients after any subtotal or total colectomy; Unwillingness to participate or who is considered incompetent to give an informed consent; Pregnant or breastfeeding women.