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临床试验/NCT00625066
NCT00625066已完成不适用

Tennessee Colorectal Polyp Study

Vanderbilt University4 个研究点 分布在 1 个国家目标入组 8,108 人开始时间: 2003年1月1日最近更新:
适应症

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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Wei Zheng

Professor

Vanderbilt University

研究点 (4)

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