Back to resultsParticipation in Competing Strategies for Colorectal Cancer Screening - a Randomized Health Services Study Within the National Screening Program in Poland (PICCOLINO)
Primary Purpose
Colorectal Cancer
Status
Unknown status
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
Offering a choice for colorectal cancer screening
Offering an alternative colorectal cancer screening method
Sponsored by
About this trial
This is an interventional health services research trial for Colorectal Cancer focused on measuring Colorectal Cancer Screening
Eligibility Criteria
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.
Sites / Locations
- Maria Sklodowska-Curie Institute - Oncology CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
No Intervention
Experimental
Experimental
Arm Label
Current screening practice.
Sequential screening strategy.
Multiple options screening strategy.
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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%).
Full Information
NCT ID
NCT03790475
First Posted
December 21, 2018
Last Updated
December 28, 2018
Sponsor
Maria Sklodowska-Curie National Research Institute of Oncology
Collaborators
Ministry of Health, Poland, Centre of Postgraduate Medical Education
1. Study Identification
Unique Protocol Identification Number
NCT03790475
Brief Title
Participation in Competing Strategies for Colorectal Cancer Screening - a Randomized Health Services Study Within the National Screening Program in Poland
Acronym
PICCOLINO
Official Title
Participation In Competing Strategies for COLorectal Cancer screenINg - a randOmized Health Services Study Within the National Screening Program in Poland(PICCOLINO)
Study Type
Interventional
2. Study Status
Record Verification Date
December 2018
Overall Recruitment Status
Unknown status
Study Start Date
August 25, 2018 (Actual)
Primary Completion Date
December 31, 2019 (Anticipated)
Study Completion Date
December 31, 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Maria Sklodowska-Curie National Research Institute of Oncology
Collaborators
Ministry of Health, Poland, Centre of Postgraduate Medical Education
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer
Keywords
Colorectal Cancer Screening
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
12298 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Current screening practice.
Arm Type
No Intervention
Arm Description
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.
Arm Title
Sequential screening strategy.
Arm Type
Experimental
Arm Description
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.
Arm Title
Multiple options screening strategy.
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Offering a choice for colorectal cancer screening
Intervention Description
Persons randomized to the multiple options screening strategy group will receive a postal invitation offering a choice between FIT and colonoscopy.
Intervention Type
Other
Intervention Name(s)
Offering an alternative colorectal cancer screening method
Intervention Description
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.
Primary Outcome Measure Information:
Title
Completion of the assigned screening strategy within 18 weeks of enrollment
Description
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
Secondary Outcome Measure Information:
Title
Diagnostic yield for CRC and advanced adenomas
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Michal Filip Kaminski, MD, PhD
Phone
+48 605438330
Email
kaminski.mf@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Nastazja Dagny Pilonis, MD
Phone
+48 510291110
Email
nastazja@gmail.com
Facility Information:
Facility Name
Maria Sklodowska-Curie Institute - Oncology Center
City
Warsaw
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michal Filip Kaminski, MD, PhD
Phone
+48 605438330
Email
mfkaminski@coi.waw.pl
First Name & Middle Initial & Last Name & Degree
Nastazja Dagny Pilonis, MD
Phone
+48 510291110
Email
nastazja@gmail.com
12. IPD Sharing Statement
Citations:
PubMed Identifier
33307024
Citation
Pilonis ND, Bugajski M, Wieszczy P, Rupinski M, Pisera M, Pawlak E, Regula J, Kaminski MF. Participation in Competing Strategies for Colorectal Cancer Screening: A Randomized Health Services Study (PICCOLINO Study). Gastroenterology. 2021 Mar;160(4):1097-1105. doi: 10.1053/j.gastro.2020.11.049. Epub 2020 Dec 9.
Results Reference
derived
Learn more about this trial
Participation in Competing Strategies for Colorectal Cancer Screening - a Randomized Health Services Study Within the National Screening Program in Poland
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