Tennessee Colorectal Polyp Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 8,108
- 试验地点
- 4
- 主要终点
- Collection of questionnaires and medical records
研究概览
简要总结
RATIONALE: Collecting and storing samples of tissue, blood, and other body fluids to test in the laboratory and gathering information about health and lifestyle from participants may help doctors learn more about cancer risk factors.
PURPOSE: This clinical trial is looking at biological, genetic, and lifestyle risk factors for developing colorectal adenomas or polyps in participants undergoing colonoscopy.
详细描述
OBJECTIVES:
- To recruit 7,000 participants who are planning to undergo colonoscopy.
- To collect questionnaires and medical records from these participants.
- To collect biological samples, including urine, blood, buccal cells and/or saliva, rectal tissue, and colorectal polyps from these participants.
- To evaluate risk factors and other differences between participants found to have polyps and those who do not have polyps.
OUTLINE: Participants undergo screening colonoscopy and removal of any polyps.
Within 1 month of colonoscopy, participants undergo a 30-minute telephone interview and/or complete a mail survey to provide information on lifestyle and medical history that may be related to colorectal polyp risk. Participants who undergo removal of polyps during their colonoscopy also complete a 20-minute survey at their 3-year follow-up colonoscopy. Participants' medical records may also be reviewed.
Blood samples are collected at the time of colonoscopy. Some participants may also provide blood samples 1-2 weeks prior to colonoscopy. Tissue from the bisected portions of colorectal polyps > 5 mm in size that are removed during colonoscopy is also obtained. Some participants may also undergo normal colorectal tissue sample and saliva sample collection at the time of colonoscopy and urine sample collection 2 days prior to, during, and/or 8 weeks after colonoscopy.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 40 Years 至 75 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Collection of questionnaires and medical records
Recruitment of 7,000 participants who are planning to undergo colonoscopy
Collection of biological samples, including urine, blood, buccal cells and/or saliva, rectal tissue, and colorectal polyps
Evaluation of risk factors and other differences between participants found to have polyps and those who do not have polyps
次要结局
未报告次要终点
研究者
Wei Zheng
Professor
Vanderbilt University
