Mycotoxin Exposure and Dietary Habits in Colorectal Cancer Prevention and Development Among Polish Population
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Completion of the assigned screening strategy
研究概览
简要总结
The aim of the study is the determination of the zearalenone and its metabolites (α and β) level in the blood plasma and faeces of patients at increased risk of cancer, in relation to the nutrition data (FFQ) and information on the quality of life dependent on health (WHOQOL-BREF).
The study is performer within the framework of the Polish Colonoscopy Screening Program. Within the study 100 volunteers between 50 and 65 years of age. while, the colonoscopies will be performed in Provincial Specialist Hospital in Olsztyn. Patients with positive test result, who have been diagnosed with polyps or cancer, will be assigned to risk group. The study has been approved by a local bioethics committee.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Men and women aged from 50 to 65 years residing in Poland.
排除标准
- •subjects requiring long-term care due to somatic, mental retardation or other mental illness.
- •history of colorectal resection.
结局指标
主要结局
Completion of the assigned screening strategy
时间窗: Within 8 weeks of enrollment
Completion of the assigned screening strategy within 8 weeks of enrollment defined as: \* current screening strategy: documented screening colonoscopy.
次要结局
- Analysis of the concentration of the mycotoxin(5 month)
- Characteristics of gut bacterial(6 month)
- Determination of anthropometric data(4 weeks)
研究者
Tomasz Sawicki
Principal Investigator
University of Warmia and Mazury in Olsztyn