Actively Recruiting
Mesalamine for Colorectal Cancer Prevention Program in Lynch Syndrome
Led by Ann-Sofie Backman · Updated on 2024-12-17
150
Participants Needed
8
Research Sites
1227 weeks
Total Duration
On this page
Sponsors
A
Ann-Sofie Backman
Lead Sponsor
T
The Swedish Research Council
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Mesalamine for Colorectal Cancer Prevention Program in Lynch Syndrome
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Proven tumor-free carriers of a germline pathologic mutation in one of the MMR genes including MLH1, MSH2 (including EpCAM), and MSH6, including patients with endoscopically removed polyps
- Male or female subjects aged 30 years or older
- Females post-menopausal for more than 1 year or females of childbearing potential using a highly effective contraception method with less than 1% failure rate, or agreeing to abstain from heterosexual activity during treatment
- Negative pregnancy test for females of childbearing potential at screening and before randomization
- Signed written informed consent prior to study inclusion
You will not qualify if you...
- Presence of colorectal benign neoplasia that cannot be removed endoscopically (patients with removed adenomas can be included)
- Carriers of germline mutations in PMS2
- History of stage 3 or 4 colorectal cancer
- Presence of metastatic disease
- Regular daily use of aspirin (≥100mg), NSAIDs, or COX-2 inhibitors for more than 3 continuous months within the last year
- Hypersensitivity to 5-ASA
- Patients after subtotal or total colectomy
- Colorectal surgery within the previous 6 months
- Unwillingness or inability to provide informed consent
- Pregnant or breastfeeding women
- Participation in another clinical study with investigational medicinal product within 1 month prior to screening
- Renal insufficiency with glomerular filtration rate below 30 ml/min/1.73m2
- Severe liver disease or liver failure with liver enzymes above 3 times upper limit of normal
- Current or history of serious psychiatric disorder, alcohol or drug abuse impacting safety or compliance
- Prior myocarditis or pericarditis
- Other severe acute or chronic medical conditions including severe lung, kidney, or heart disease, psychiatric conditions, or lab abnormalities increasing study risk or limiting compliance
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 8 locations
1
Aalborg University Hospital
Aalborg, Denmark, 9000
Not Yet Recruiting
2
Hvidovre Hospital
Hvidovre, Denmark, 2650
Actively Recruiting
3
Sahlgrenska University Hsospital
Gothenburg, Gothenburg, Sweden, 416 85
Actively Recruiting
4
Skåne University Hospital
Malmö, Skåne County, Sweden, 205 02
Actively Recruiting
5
Ersta Hospital/Ersta Diakoni
Stockholm, Sweden, 116 91
Actively Recruiting
6
Karolinska University Hospital
Stockholm, Sweden, 171 76
Active, Not Recruiting
7
Norrland University Hospital
Umeå, Sweden, 901 85
Actively Recruiting
8
Akademiska hospital
Uppsala, Sweden, 751 85
Not Yet Recruiting
Research Team
A
Ann-Sofie Backman, MD PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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