Participation In Competing Strategies for COLorectal Cancer screenINg - a randOmized Health Services Study Within the National Screening Program in Poland(PICCOLINO)
试验速览
- 阶段
- 不适用
- 入组人数
- 12,298
- 试验地点
- 1
- 主要终点
- Completion of the assigned screening strategy within 18 weeks of enrollment
研究概览
简要总结
The PICCOLINO is a randomized health services study performed within the framework of the Polish Colonoscopy Screening Program (PCSP) in Poland.
Within the study 12,298 eligible persons between 55 and 64 years of age will be drawn from the Population Registry and randomly assigned in a 1:1:1 ratio to receive an invitation to participate in one of the three screening strategies: (I) postal invitation to colonoscopy and a re-invitation to colonoscopy for initial non-responders, (II) postal invitation for screening using fecal immunochemical test (FIT) for non-responders and subjects refusing a colonoscopy, or (III) postal invitation offering a choice between FIT and colonoscopy.
Colonoscopies will be performed in seven local centers participating in the study. FITs will be analyzed in the central laboratory. Subjects with positive FIT result will be recommended to undergo colonoscopy.
The primary outcome is participation with CRC screening within 18 weeks after enrollment, defined as completion of colonoscopy, or completion of FIT along with colonoscopy for positive FIT result. Secondary outcome will be diagnostic yield for advanced neoplasia (CRC or advanced adenoma). The study has been approved by a local bioethics committee.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 55 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women aged 55 to 64 years residing in Poland and assigned to be invited to screening within the Polish Colonoscopy Screening Program .
排除标准
- •information of a selected subject death informed by family, neighbors or post office that has not been included in the Personal Identity Number (PESEL) system.
- •addressees of letters that have been returned by the post office.
- •subjects requiring long-term care due to somatic, psychosocial reasons or with mental disability.
- •history of colorectal resection.
研究组 & 干预措施
Current screening practice.
Subjects randomized into this group will receive named invitations for colonoscopy with pre-specified date, contact details of dedicated screening center. Invitations will be sent 6 weeks prior to suggested date of screening test. All subjects not responding to the invitation will receive a reminder letter 3 weeks prior to proposed appointment date. Additionally, a re-invitation for colonoscopy (screening test in 6 weeks) will be sent to participants not responding to the first invitation and the reminding letter.
Sequential screening strategy.
Subjects randomized into this group will be initially invited to participate in a screening colonoscopy as per group 1. All subjects who will refuse colonoscopy or do not respond to invitation within 6 weeks since the first letter, will receive another invitation letter with FIT test enclosed.
The screening office will contact persons with a positive test result in order to determine the date of the colonoscopy appointment.
A negative test result will be sent together with a recommendation to have another screening test performed 2 years later and information about the possible delivery of the test in two years.
干预措施: Offering an alternative colorectal cancer screening method (Other)
Multiple options screening strategy.
Subjects in this group will receive a letter with an offer to choose between colonoscopy or FIT screening.
The first letter will include an invitation with a scheduled date of colonoscopy (in 6 weeks) and a FIT kit.
Three weeks before a scheduled date of colonoscopy subjects randomized into this group will receive a reminder letter with an information about proposed screening methods. After the scheduled date of the colonoscopy examination, subjects who will not respond to the invitation for colonoscopy and will not send the FIT test back to the laboratory will receive another invitation for colonoscopy (in 6 weeks) and a FIT kit.
干预措施: Offering a choice for colorectal cancer screening (Other)
结局指标
主要结局
Completion of the assigned screening strategy within 18 weeks of enrollment
时间窗: Within 18 weeks of enrollment
Completion of the assigned screening strategy within 18 weeks of enrollment defined as: * current screening strategy: documented screening colonoscopy, * sequential and multiple options strategies: documented colonoscopy, or receipt of FIT containing stool specimen. A positive FIT result requires subsequent documented colonoscopy to qualify as completed.
次要结局
- Diagnostic yield for CRC and advanced adenomas(Within 18 weeks of enrollment)
研究者
Michal F. Kaminski, MD, PhD
MD, PhD
Maria Sklodowska-Curie National Research Institute of Oncology