Augmentation of Screening Colonoscopy With Fecal Immunochemical Testing
试验速览
- 阶段
- 不适用
- 入组人数
- 4,100
- 试验地点
- 6
- 主要终点
- rate of significant colon neoplasia among those who enter a screening or surveillance program with FIT testing added at yearly intervals vs. that of "usual care" patients in the same patient population.
研究概览
简要总结
The study will determine if adding fecal immunochemical testing (FIT) at yearly intervals to a colonoscopy screening program will improve colon cancer detection rates.
详细描述
This study will evaluate the benefit of augmenting a compliant College of Gastroenterology colorectal cancer screening program with the addition of yearly FIT testing at two critical points in the current recommended follow up: 1. In patients found to have adenomatous polyps for the first time after colonoscopy, the addition of FIT in yearly intervals following index colonoscopy and 2. For subjects with "clean" colonoscopies (no polyps found), the addition of FIT at yearly intervals starting in year 6 and continuing to year 10 or subsequent colonoscopy. Current screening guidelines do not recommend the combination of colonoscopy and FOBT.
Two factors plague an effective colon cancer screening program: 1) a less than 100% sensitivity (95% ) for optical colonoscopy to detect colon cancer, and 2) Limitations of guaiac based stool testing: low sensitivity ( 5% in single use) for detection of colon cancer and the traditional gFOBT is cumbersome for patients to perform, impeding patient acceptance and adherence.
FIT offers a FOBT with improved sensitivity (65% for invasive colon cancer) and improved specificity and better patient compliance. The addition of FIT after initial colonoscopy could be applied to a screening program and thereby salvage "missed" lesions by increased detection rates
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Group I (positive colonoscopy)
- •18 to 75 years of age
- •male or female
- •willing to provide written informed consent
- •In the event that the colonoscopy is incomplete, or polypectomy is partial, the above patients are eligible if a successful examination is completed within 6 months of the inadequate exam.
- •Group II (negative colonoscopy)
- •50 to 69 years of age
- •Male or female
- •Willing to provide written informed consent
- •In the event that the colonoscopy is incomplete, the patient is eligible if a successful examination is completed within 6 months of the inadequate exam.
排除标准
- •Group I (positive colonoscopy)
- •chronic use of coumadin
- •history of previous GI malignancy, inflammatory bowel disease (Crohns disease, ulcerative colitis)
- •age or health status contraindicates repeat colonoscopy
- •history of Familial Polyposis or Hereditary Nonpolyposis Colon Cancer Syndrome
- •The index colonoscopy resulted in a perforation requiring surgical repair
- •An otherwise qualifying colonoscopy is followed by a recommendation for repeat colonoscopy in ≤ 1 yr.
- •Group II (negative colonoscopy)
- •chronic use of coumadin
- •history of previous GI malignancy, inflammatory bowel disease (Crohns disease, ulcerative colitis)
- •age or health status contraindicates repeat colonoscopy
- •history of Familial Polyposis or Hereditary Nonpolyposis Colon Cancer Syndrome
- •The index colonoscopy resulted in a perforation requiring surgical repair
- •Significant family history resulting in a recommendation for repeat colonoscopy in 5 years or less
结局指标
主要结局
rate of significant colon neoplasia among those who enter a screening or surveillance program with FIT testing added at yearly intervals vs. that of "usual care" patients in the same patient population.
时间窗: yearly
次要结局
- the pathology found at repeat colonoscopy in each group.(Yearly)