{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,12,4]],"date-time":"2025-12-04T21:30:32Z","timestamp":1764883832293,"version":"3.46.0"},"reference-count":17,"publisher":"BMJ","issue":"11","license":[{"start":{"date-parts":[[2025,11,9]],"date-time":"2025-11-09T00:00:00Z","timestamp":1762646400000},"content-version":"unspecified","delay-in-days":8,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"name":"Swedish research council","award":["2017-00557"],"award-info":[{"award-number":["2017-00557"]}]},{"name":"ALF, Medicin Region Stockholm","award":["FoUI-988411, FoUI-974948"],"award-info":[{"award-number":["FoUI-988411, FoUI-974948"]}]},{"name":"Swedish Cancer Society, Cancerfonden","award":["21 1500 Fk, 22 2294 Pj, 24 0821 FK"],"award-info":[{"award-number":["21 1500 Fk, 22 2294 Pj, 24 0821 FK"]}]}],"content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["BMJ Open"],"accepted":{"date-parts":[[2025,10,27]]},"published-print":{"date-parts":[[2025,11]]},"abstract":"<jats:sec>\n                    <jats:title>Introduction<\/jats:title>\n                    <jats:p>Lynch syndrome (LS) carriers have a 20\u201346% lifetime risk of colorectal cancer (CRC) due to mismatch repair gene variants. Mesalamine (5-ASA, 5-aminosalicylic acid), used safely in patients with ulcerative colitis, may reduce CRC risk in LS by decreasing microsatellite instability, a key driver of LS-related cancer. This study evaluates 5-ASA\u2019s efficacy as a tolerable chemopreventive drug, aiming to improve long-term CRC prevention in LS.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods and analysis<\/jats:title>\n                    <jats:p>This multicentre, multinational, randomised, double-blind, two-arm, phase II clinical study will compare the effects of a 2-year daily intake of 5-ASA (2000\u2009mg) to placebo in LS carriers. The primary objective is to assess whether mesalamine reduces colorectal neoplasia, both benign and malignant, compared with placebo in LS carriers, as detected by colonoscopy at the end of the treatment period (24 months\u00b11\u2009month) and on study completion. Secondary objectives include evaluating whether 5-ASA reduces neoplasia\/tumour multiplicity and progression compared with placebo at specified time points, examining variations in the effects of 5-ASA versus placebo based on cancer history, sex and age (&lt;45 years vs \u226545 years), and assessing the safety of 5-ASA in LS carriers.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Ethics and dissemination<\/jats:title>\n                    <jats:p>The trial is currently open for enrolment, having received ethical approval from the Regional Ethical Review Board in Stockholm and funding from the Swedish Research Council. The study protocol is the finalised V.10.0 (11 April 2024), transitioned to the European Clinical Trials Information System. LS remains underdiagnosed, which may limit recruitment. The results are of global interest and will be published in peer-reviewed journals and presented at scientific conferences.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Trial registration number<\/jats:title>\n                    <jats:p>\n                      ClinicalTrials.gov:\n                      <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"clintrialgov\" xlink:href=\"NCT04920149\">NCT04920149<\/jats:ext-link>\n                      . EudraCT: 2019-003011-55. EU CT: 2024-514765-19-01.\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.1136\/bmjopen-2025-100082","type":"journal-article","created":{"date-parts":[[2025,11,11]],"date-time":"2025-11-11T08:56:39Z","timestamp":1762851399000},"page":"e100082","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":0,"title":["Mesalamine for Colorectal Cancer Prevention Programme in Lynch syndrome (MesaCAPP): a multicentre, multinational, randomised, two-arm, double-blind, phase II clinical study with mesalamine or placebo in carriers with Lynch syndrome \u2013 a study protocol"],"prefix":"10.1136","volume":"15","clinical-trial-number":[{"clinical-trial-number":"nct04920149","registry":"10.18810\/clinical-trials-gov"},{"clinical-trial-number":"nct04920149","registry":"10.18810\/clinical-trials-gov"}],"author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-6054-6692","authenticated-orcid":false,"given":"Ann-Sofie","family":"Backman","sequence":"first","affiliation":[{"name":"Dept. of Medicine, Karolinska Institutet, Stockholm, Sweden"},{"name":"Dept. of Medicine, Ersta Hospital, Stockholm, Sweden"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0009-0004-5725-1414","authenticated-orcid":false,"given":"Alexander","family":"Frank","sequence":"additional","affiliation":[{"name":"Dept. of Medicine, Ersta Hospital, Stockholm, Sweden"},{"name":"Department of Medicine, Huddinge, Karolinska Institute, Stockholm, Sweden"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Lars Joachim","family":"Lindberg","sequence":"additional","affiliation":[{"name":"Department of Clinical Medicine, University of Copenhagen, Copenhagen, Denmark"},{"name":"Copenhagen University Hospital, Copenhagen, Denmark"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"David","family":"Ljungman","sequence":"additional","affiliation":[{"name":"Dept. of Surgery, University of Gothenburg, Gothenburg, Sweden"},{"name":"Sahlgrenska Academy, Gothenburg, V\u00e4stra G\u00f6taland County, Sweden"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Gustav","family":"Silander","sequence":"additional","affiliation":[{"name":"Dept. of Radiation Sciences, Ume\u00e5 University, Ume\u00e5, Sweden"},{"name":"Norrlands University hospital, Uppsala, Austria"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Rita J","family":"Gustafsson","sequence":"additional","affiliation":[{"name":"Lund University, Lund, Sweden"},{"name":"Sk\u00e5ne University Hospital, Malm\u00f6, Sweden"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"T\u00fcnde","family":"Bozs\u00f3","sequence":"additional","affiliation":[{"name":"Lund University, Lund, Sweden"},{"name":"Sk\u00e5ne University Hospital, Malm\u00f6, Sweden"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Peter T","family":"Schmidt","sequence":"additional","affiliation":[{"name":"Dept. of Medical Sciences, Uppsala University, Uppsala, Sweden"},{"name":"Uppsala University Hospital, Uppsala, Sweden"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Michael","family":"Ingre","sequence":"additional","affiliation":[{"name":"Dept. of Medicine, Karolinska Institutet, Stockholm, Sweden"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Martina","family":"Mittlbock","sequence":"additional","affiliation":[{"name":"Medizinische Universitat Wien, Wien, 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