Polyprev Study: Randomized, Multicenter, Controlled Trial Comparing Fecal Immunochemical Test With Endoscopic Surveillance After Advanced Adenoma Resection in Fecal Immunochemical Test Colorectal Cancer Screening Programs.
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 3,788
- 试验地点
- 3
- 主要终点
- Adverse effects
研究概览
简要总结
Colorectal cancer (CRC) screening programs have been implemented to reduce the burden of the disease. When an advanced colonic lesions is detected, it is recommended to perform endoscopic surveillance with different intervals between explorations. Although the reduction in CRC incidence, endoscopic surveillance is producing a considerable increase in the number of colonoscopies. However, participation in CRC screening programs based on the fecal immunochemical test (FIT) could be a non inferior alternative to endoscopic surveillance.
Based on this hypothesis, the research group have designed a randomized clinical trial within the population CRC screening programs to compare FIT surveillance to endoscopic surveillance in patients with advanced lesions resected.
详细描述
Colorectal cancer (CRC) is one of the most common malignancies in western countries. CRC screening programs have been implemented in order to reduce the burden of the disease. Screening programs in Spain are based on the biennial detection of fecal hemoglobin with a fecal immunochemical test (FIT) and a diagnostic colonoscopy if positive. The detection of at least one advanced adenoma or serrated lesion defines a high risk situation for metachronous CRC. This group of patients is recommended to perform endoscopic surveillance with different intervals between explorations. Endoscopic surveillance reduces mortality only 1.7% and increases the number of colonoscopies by 62% with an additional cost of € 68,000 for an increase of 0.9 years of life. Moreover, colonoscopy is a procedure associated with potentially serious side effects.
A recently British study shows that with a cut-off of 10 µg/g, FIT has a higher sensitivity and specificity for CRC with a significant cost reduction compared to colonoscopy surveillance. Additionally, most of the population prefers non-invasive faecal tests rather than colonoscopy.
Based on this evidence, the research group have designed a multicenter, randomized clinical trial to compare the 10 year CRC incidence after resection of advanced colonic lesions detected within CRC screening programs between endoscopic surveillance and participation in CRC screening programs based on FIT.
Apart from this purpose, the investigators will also assess the values and preferences regarding surveillance and risk of CRC. Further, the research group will evaluate the relationship between Mediterranean diet and physical activity with the detection of advanced adenomas and CRC.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 50 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Individuals aged 50 to 65 years.
- •Individuals with at least one advanced adenoma (tubulovillous or villous histology, high grade dysplasia or ≥ 10mm), and / or at least three non-advanced adenomas detected and resected completely within the population-based CRC screening program.
排除标准
- •Personal history of CRC.
- •Colonic lesion ≥10mm resected without histological diagnosis.
- •More than 10 adenomas in baseline colonoscopy.
- •Serrated polyposis syndrome.
- •Two or more first-degree relatives with CRC.
- •Hereditary predisposition to CRC.
- •Relevant comorbidity with life expectancy inferior to 5 years.
- •Colonoscopy with incomplete mucosal examination.
- •Incomplete resection of baseline lesions.
- •Non-acceptance after reading the informed consent.
研究组 & 干预措施
Group I
Annual FIT surveillance
干预措施: Annual FIT (Diagnostic Test)
Group II
Endoscopic surveillance
干预措施: Endoscopic surveillance. (Procedure)
结局指标
主要结局
Adverse effects
时间窗: 10 years
Adverse effects associated with surveillance are defined as complications that require hospitalization. Those related to the surgical treatment of benign colonic lesions will be included as adverse effects.
Mortality
时间窗: 10 years
The deaths and their cause will be collected: associated with CRC, associated with adverse effects of screening or unrelated.
Rate of advanced colonic lesions
时间窗: 10 years
Advanced colonic lesions will be defined as advanced adenomas (at least 10mm, hairy histology or high grade dysplasia) or advanced serrated lesions (at least 10mm or with dysplasia).
Frequency of participation in the surveillance strategy
时间窗: 10 years
According to the methodology of the information systems of the screening programs, three categories will be defined: non-participation, irregular participation, regular participation.
Rate of invasive CRC
时间窗: 10 years
It is the main outcome of the study. Invasive CRC is defined as colonic adenocarcinoma that invades the submucosa. Adenocarcinomas in situ and intramucosal carcinomas will not be considered as invasive CRC.
Rate of interval CRC
时间窗: 10 years
Interval CRC is defined as the CRC detected between two organized surveillance (FIT or colonoscopy).
次要结局
- CRC, adenoma and advanced serrated lesions at three years(3 years)
- Preferences of the subjects(2 years)
- Physical activity(3 years)
- Mediterranean lifestyle(3 years)