EUCTR2017-000722-35-DK进行中(未招募)1 期
Perioperative metformin treatment for colon cancer - a randomized trial - MECORA
Ismail Gögenur0 个研究点目标入组 48 人开始时间: 2017年5月8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
- 48
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
- •-Patients with adenocarcinoma of the colon planned for elective curative intended surgery at Slagelse hospital
- •-Age of 18 or above
- •-Must be able to understand and sign informed content
- •-Sufficient amount of representative tumor material from the biopsies taken at the initial colonoscopy must be present
- •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 15
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 33
排除标准
- •-Patients diagnosed with diabetes mellitus
- •-Patients who are receiving or have received metformin or other oral antidiabetics
- •-Impaired kidney function (eGFR < 60mL/min)
- •-Severe liver disease (defined as transaminases above X 3 normal levels)
- •-Participation in another pharmacological intervention trial
- •-Predictable poor compliance (for instance not speaking fluent Danish, mentally impaired)
- •-Presenting with metastatic disease
- •-Patients undergoing neoadjuvant chemotherapy
- •-Pregnancy or lactation (fertile women must have a negative serum or urine pregnancy test to participate)
- •-Fertile women who do not use safe contraception during the study period.
研究者
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