Participation in Competing Strategies for Colorectal Cancer Screening - a Randomized Health Services Study Within the National Screening Program in Poland (PICCOLINO)

Participation In Competing Strategies for COLorectal Cancer screenINg - a randOmized Health Services Study Within the National Screening Program in Poland(PICCOLINO)

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.

Study Overview

• Status: Unknown
• Conditions: Colorectal Cancer
• Intervention / Treatment: Other: Offering an alternative colorectal cancer screening method; Other: Offering a choice for colorectal cancer screening

• Study Type: Interventional
• Enrollment (Anticipated): 12298
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Poland
  • Warsaw, Poland
    • Recruiting
    • Maria Sklodowska-Curie Institute - Oncology Center
    • Contact: Michal Filip Kaminski, MD, PhD; Phone Number: +48 605438330; Email: mfkaminski@coi.waw.pl
    • Contact: Nastazja Dagny Pilonis, MD; Phone Number: +48 510291110; Email: nastazja@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 55 years to 64 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: 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.
Experimental: 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.	Other: Offering 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.
Experimental: 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Within 18 weeks of enrollment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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%).	Within 18 weeks of enrollment

Collaborators and Investigators

• Sponsor: Maria Sklodowska-Curie National Research Institute of Oncology
• Collaborators: Centre of Postgraduate Medical Education; Ministry of Health, Poland

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): August 25, 2018
• Primary Completion (Anticipated): December 31, 2019
• Study Completion (Anticipated): December 31, 2019

Study Registration Dates

• First Submitted: December 21, 2018
• First Submitted That Met QC Criteria: December 28, 2018
• First Posted (Actual): December 31, 2018

Study Record Updates

• Last Update Posted (Actual): December 31, 2018
• Last Update Submitted That Met QC Criteria: December 28, 2018
• Last Verified: December 1, 2018

More Information

Terms related to this study

• Keywords: Colorectal Cancer Screening
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms
• Other Study ID Numbers: 43/PB/2018

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No