Prevalence and Topography of Adenomas in 40-49 Year Old Patients With a Family History of Colon Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,623
- 试验地点
- 6
- 主要终点
- Prevalence of advanced adenomas among 40-49 year old individuals with and without a family history of colorectal cancer
研究概览
简要总结
Conflicting guideline recommendations for screening colonoscopy result due to scant data upon which to develop appropriate recommendations. No previous study has compared the prevalence of advanced adenomas or adenomas (any size) among 40-49 year old individuals with a first degree relative (FDR) with colorectal cancer (CRC) versus 40-49 year old average risk individuals with no family history of CRC. The purpose of this study is to determine the prevalence of colon adenomas in 40-49 year old individuals and identify risk factors associated with the presence of advanced adenomas. This data will provide evidence to determine appropriate colon cancer screening guidelines in 40-49 year old persons with a family history of colon polyps or colorectal cancer.
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 49 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •40-49 year old asymptomatic men and women referred for colorectal cancer screening with a family history of CRC in a first degree relative;
- •40-49 year old asymptomatic men and women referred for colorectal cancer screening with a family history of polyps in a first degree relative;
- •40-49 year old men and women without a family history of CRC or polyps in a first degree relative who are referred for colonoscopy to evaluate scant hematochezia characterized as red blood on toilet tissue after wiping or small droplets of blood on stool or in toilet water after evacuating stool, abdominal discomfort or altered bowel habits characterized as constipation or diarrhea.
排除标准
- •Personal history of iron deficiency anemia within six months of referral;
- •Personal history of iron deficiency without anemia within six months of referral;
- •Personal history of (+) FOBT within one year of referral;
- •Personal history of previous colonoscopy or barium enema within the past 10 years;
- •Personal history of previous flexible sigmoidoscopy in the past 5 years;
- •Personal history of adenoma, colorectal cancer, inflammatory bowel disease, HNPCC, or familial adenomatous polyposis (FAP);
- •Unintentional weight loss > 10 lbs within the previous six months;
- •Individuals with family history of CRC AND scant hematochezia;
- •Inability to speak and read English.
结局指标
主要结局
Prevalence of advanced adenomas among 40-49 year old individuals with and without a family history of colorectal cancer
时间窗: Data analysis will begin September 2014 for a duration of three months.
The outcome will be assessed after the completion of patient recruitment at all locations in August 2014. Advanced adenomas are defined as greater than or equal to 10 mm (1 cm). The presence of adenomas is determined be reviewing patient medical records and pathology reports.
次要结局
- Absolute prevalence of advanced adenomas in 40-49 year olds with a family history of colorectal cancer(Data analysis will begin September 2014 for a duration of three months.)
- Absolute prevalence of advanced adenomas in 40-49 year old individuals with a family history of colorectal polyps(Data analysis will begin September 2014 for a duration of three months.)
研究者
Philip Schoenfeld
Professor of Medicine
University of Michigan