2024-514765-19-01招募中2 期
Mesalamine for colorectal cancer prevention program in Lynch syndrome
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 150
- 试验地点
- 8
- 主要终点
- Occurrence of any colorectal neoplasia (both benign and malignant tumors)
研究概览
简要总结
To test whether mesalamine (5-ASA) reduces the occurence of any colorectal neoplasia (both benign and malignant tumours) compared to placebo in Lynch syndrome (LS) patients as detected by any colonoscopy until the end of treatment (24 months + 3 months) and end of study
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 是
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 with less than 1% failure rate (i.e. oral hormonal contraceptives, hormone implants, hormone injections, sterilization, hormonal or copper intrauterine device, sterilized/vasectomized partner, or diaphragm in combination with a condom, spermicide or birth control pills) or should agree to abstain from heterosexual activity during treatment period. Females of childbearing potential must have a negative pregnancy test at screening and randomization
- •Signed written informed consent prior to inclusion in the study
排除标准
- •Presence of colorectal endoscopically non-removable malign neoplasia (patient can be included if the adenoma is removed)
- •Unwillingness to participate or who is considered unable to give an informed consent
- •Pregnant or breastfeeding women
- •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
- •Prior history of myocarditis or pericarditis. Other severe acute or chronic medical condition (such as severe chronic lung (COPD, including asthma), kidney or heart diseases), duodenal ulcer, haemorrhagic diathesis or psychiatric condition or other abnormal clinical sign 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
- •Carriers of germline mutations in PMS2
- •Patients with history of stage 3 and 4 colorectal cancer (CRC) are excluded
- •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
- •Patients after any subtotal or total colectomy
- •Colorectal surgery within the previous 6 months
结局指标
主要结局
Occurrence of any colorectal neoplasia (both benign and malignant tumors)
Occurrence of any colorectal neoplasia (both benign and malignant tumors)
次要结局
- The number of colorectal neoplasia (both benign and malignant tumors) per patient
- The tumor progress in the 4 ordered stages
- The dependence of treatment effects on history of colorectal cancer, sex and patients age (<45 years and ≥45 years)
- Safety data are described and compared between groups in an exploratory manner
研究者
Ann-Sofie Backman
Scientific
Karolinska Institutet
研究点 (8)
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