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Prevention study for Lynch Syndrome
Official title Mesalamine for Colorectal Cancer Prevention Program in Lynch Syndrome
ClinicalTrials.gov ID: NCT04920149
What this study is testing
What is Mesalamine?
Mesalamine is an investigational medicine, given as an once-daily, being studied as a potential treatment for lynch syndrome.
Also referred to as Mesalazine, Pentasa sachet.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 30 and older
You may be able to join if
- Proven tumor-free (including patients in which the polyps are removed endoscopically) carriers of a germline pathologic mutation in one of the MMR...
- Male or female people 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...
- Signed written informed consent prior to inclusion in the study
You likely can't join if
- 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
See the full eligibility 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 people 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...
- Signed written informed consent prior to inclusion in the study
- 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 how well it works 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...
The study team makes the final eligibility decision.
Where it's taking place
- Aalborg, Denmark
- Hvidovre, Denmark
- Gothenburg, Gothenburg, Sweden
- Malmö, Skåne County, Sweden
- Stockholm, Sweden
- Umeå, Sweden
- Uppsala, Sweden
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 30 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Aalborg, Denmark; Hvidovre, Denmark; Gothenburg, Gothenburg, Sweden; Malmö, Skåne County, Sweden; Stockholm, Sweden; Umeå, Sweden and 1 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.