Colorectal Cancer
Conditions
Keywords
Colorectal Cancer Screening
Brief summary
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.
Interventions
OTHEROffering a choice for colorectal cancer screening
Persons randomized to the multiple options screening strategy group will receive a postal invitation offering a choice between FIT and colonoscopy.
OTHEROffering an alternative colorectal cancer screening method
Persons randomized to the sequential screening strategy group will receive a postal invitation to the colonoscopy followed by a postal invitation for screening using FIT for non-responders and subjects refusing colonoscopy.
Sponsors
Ministry of Health, Poland
Centre of Postgraduate Medical Education
Maria Sklodowska-Curie National Research Institute of Oncology
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
55 Years to 64 Years
Healthy volunteers
No
Inclusion criteria
Men and women aged 55 to 64 years residing in Poland and assigned to be invited to screening within the Polish Colonoscopy Screening Program .
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Completion of the assigned screening strategy within 18 weeks of enrollment | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Diagnostic yield for CRC and advanced adenomas | Within 18 weeks of enrollment | Advanced adenoma defined as adenoma \>1 cm in size, or with high-grade dysplasia, or with villous component (\>25%). |
Countries
Poland
Contacts
Primary ContactMichal Filip Kaminski, MD, PhD
Backup ContactNastazja Dagny Pilonis, MD
Outcome results
None listed