NCT00906997已完成不适用
Colorectal Cancer Screening in Average-risk Population: a Multicenter, Randomized Control Trial Comparing Immunochemical Fecal Occult Blood Testing Versus Colonoscopy.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 55,498
- 试验地点
- 9
- 主要终点
- Colorectal cancer-related mortality
研究概览
简要总结
Aims:
- To compare the efficacy of biennial immunochemical fecal occult blood test (iFOBT) versus colonoscopy every 10 years for the reduction of colorectal cancer-related mortality at 10 years in average-risk population.
- To determine the compliance and complications associated with both strategies.
Methods: Multicenter, randomized, controlled study in 8 Spanish regions (Aragón, Canarias, Catalunya, Euskadi, Galicia, Madrid, Murcia and Valencia).
Study groups:
- Group I: iFOBT (OC Sensor®) in one stool sample, followed by colonoscopy when a positive result.
- Group II: colonoscopy.
Sample-size calculation: 27,749 subjects in each study group (total: 55,498).
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
- 50 Years 至 69 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women aged 50-69 years
排除标准
- •Personal history of colorectal cancer, colorectal adenoma, colorectal polyposis, or inflammatory bowel disease
- •Family history of colorectal polyposis, Lynch syndrome or familial colorectal cancer (2 or more first-degree relatives diagnosed with colorectal cancer or one first-degree relative diagnosed with colorectal cancer before the age of 60)
- •Severe comorbidity
- •Previous total colectomy
- •Not signed informed consent to participate
结局指标
主要结局
Colorectal cancer-related mortality
时间窗: 10 years
次要结局
- Compliance rate(2 years)
- Complication rate(10 years)
- Colorectal cancer incidence(15 years)
- Adherence rate(10 years)
- Advanced colorectal neoplasm detection rate(2 years)
研究者
Antoni Castells
Co-principal investigator
Hospital Clinic of Barcelona
研究点 (9)
Loading locations...
相似试验
已完成
3 期
Colorectal Cancer Screening in Familiar-Risk Population: Immunochemical Fecal Occult Blood Testing Versus ColonoscopyColorectal CancerNCT01075633Enrique Quintero1,501
已完成
3 期
Comparison of Hemoccult, Magstream and OC-Sensor Faecal Occult Blood Tests in Colorectal Cancer ScreeningColorectal CancerNCT01251666University Hospital, Caen19,797
已完成
不适用
A Trial of the Implementation of iFOBT in General PracticeColorectal CancerNCT02308384University of Aarhus825
已完成
不适用
The comparative study of fecal immunochemical test-positive and negative colorectal tumors in opportunistic screeningcolorectal tumorsJPRN-UMIN000012116Digestive Disease Center , Showa University Northern Yokohama Hospital919
招募中
不适用
Immunochemical FOBT screening for colorectal cancer: yield and attendance for one- versus two-sample tests, and for second round screening with various intervals.Colorectal cancerNL-OMON26711Erasmus Medical Center, RotterdamDepartment of Gastroenterology and Hepatology12