Mesalamine for Colorectal Cancer Prevention Program in Lynch syndrome - MesaCAPP studie

Medical University of Vienna0 个研究点目标入组 170 人开始时间: 待定最近更新: 2024年2月28日

研究概览

暂无简介。

•* Proven tumor-free (including patients in which the polyps are removed endoscopically) carriers of a germline pathologic mutation on one of the MMR genes including MLH1, MSH2 (including EpCAM) en MSH6.
•* Male or female subjects with the age > 30 years
•* Signed written informed consent prior to inclusion in the study

•* Presence of colonic 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: daily use of *100mg in more than 3 continuous months within the last
•* 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 total or subtotal 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
•* 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 safety, efficacy or protocol adherence.
•* Other severe acute or chronic medical 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.

发起方