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临床试验/NCT00164944
NCT00164944已完成不适用

Colonoscopic Screening in First-degree Relatives of Hong Kong Chinese Patients With Sporadic Colorectal Cancer: a Cohort Study With Case Control Analysis

Chinese University of Hong Kong1 个研究点 分布在 1 个国家目标入组 748 人开始时间: 2004年4月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
748
试验地点
1
主要终点
To find the prevalence of adenomas and advanced neoplasms of the first degree relatives

研究概览

简要总结

To determine the prevalence of colorectal neoplasms in first degree relatives of those affected with sporadic colorectal cancer using colonoscopy as a screening tool. The prevalence will be compared to that of a defined matched cohort.

详细描述

Colorectal cancer is a second commonest tumor in Hong Kong and the second commonest cause of cancer related death. About 1 in 23 males will develop colorectal cancer in his life time. The disease tends to cluster in families. This may be a combination of factors including shared genes, shared environment or chance. Known familial syndromes occur in only about 5% of cases. The majority is not well understood and labelled sporadic colorectal cancer. The screening strategy in families of subjects with colorectal cancer has not been defined. Colonoscopy is among the most sensitive and specific screening tool for colorectal neoplasm. The current study determines the prevalence of adenomas among first degree relatives of patients diagnosed with colorectal cancer. To quantify risk in this cohort, a case control analysis is used. The prevalence of the cohort is compared to that of a control population. The control group consists of relatives of patients with normal colonoscopic findings during the same study period.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
40 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • First degree relatives (age >40 and <70) of individuals affected with sporadic colorectal cancer (those not associated with inflammatory bowel disease, familial adenomatous polyposis or HNPCC syndrome).

排除标准

  • A family history compatible with that of Hereditary Non-polyposis Colon Cancer (HNPCC) based on the Amsterdam criteria [Table 5].
  • Known Familial Adenomatous Polyposis (FAP) syndrome
  • Patients and relatives with known inflammatory bowel disease
  • Relatives that have received colonoscopy examinations in the past 5 years [details of colonoscopic examinations will be sought and information on colonic neoplasms recorded]. Those who have had barium enema examinations are eligible for trial inclusion as barium examinations often have low sensitivity and specificity for adenomas (around 70% respectively)
  • Severe cardio-pulmonary or other medical co-morbidities that preclude safe colonoscopic examination

结局指标

主要结局

To find the prevalence of adenomas and advanced neoplasms of the first degree relatives

时间窗: 7 years

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

James Yun-wong Lau

Professor

Chinese University of Hong Kong

研究点 (1)

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