EUCTR2019-003011-55-DK进行中（未招募）1 期
Mesalamine for Colorectal Cancer Prevention Program in Lynch Syndrome - MesaCAPP
Karolinska University Hospital0 个研究点目标入组 360 人开始时间: 2022年2月7日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 360
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •- 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) and MSH6.
- •- Male or female subjects with the age > 30 years.
- •- 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.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 300
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 60
排除标准
- •- Presence of colorectal endoscopically non-removable benign neoplasia (patient can be included if the adenoma is removed).
- •- Carriers of germline mutations in PMS2.
- •- History of stage 3 and 4 colorectal cancer (CRC).
- •- Presence of any metastatic disease.
- •- Regular use of acetylsalicylic acid (ASA or aspirin): 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.
- •- Subtotal or total colectomy.
- •- Colorectal surgery within the previous 6 months.
- •- Unwillingness to participate or considered unable to give an informed consent.
- •- Pregnancy or ongoing breastfeeding.
- •- Participation in another clinical study investigating another IMP within 3 months 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 efficacy or protocol adherence
- •- History of myocarditis or pericarditis. Other severe acute or chronic medical condition (such as severe chronic lung (COPD, including asthma), kidney or heart diseases) or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or ability to comply with study procedures, IMP administration and, in the judgment of the investigator, would make the subject inappropriate for entry into this study
研究者
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