An interventional study of Offering a choice for colorectal cancer screening and Offering an alternative colorectal cancer screening method in Colorectal Cancer, sponsored by Maria Sklodowska-Curie National Research Institute of Oncology. Status unknown at 1 site in Poland. Open to participants aged 55 Years to 64 Years. Per ClinicalTrials.gov, last updated 2018-12-31.
Sponsored by Maria Sklodowska-Curie National Research Institute of Oncology · Not applicable, Interventional, and Health services research
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.
5,738 studies on the registry are indexed under Colorectal Neoplasms; 1,483 are open to participants now.
This study's planned enrollment of 12,298 is above the median of 77 across 4,226 interventional studies indexed under Colorectal Neoplasms.
Browse Colorectal Neoplasms studies →Maria Sklodowska-Curie National Research Institute of Oncology is the lead sponsor of 64 studies on the registry; 13 are open to participants now.
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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:
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.
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.
Other: Offering an alternative colorectal cancer screening method
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.
Other: Offering 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.
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.
Completion of the assigned screening strategy 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.
Time frame: Within 18 weeks of enrollment
Diagnostic yield for CRC and advanced adenomas
Advanced adenoma defined as adenoma \>1 cm in size, or with high-grade dysplasia, or with villous component (\>25%).
Time frame: Within 18 weeks of enrollment
This study is status unknown, as verified in Dec 2018. You cannot join it, but the record below documents what was studied.
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Maria Sklodowska-Curie National Research Institute of Oncology