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

Colorectal Cancer Clinical Trial

— PICCOLINO  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03790475
• Other study ID #: 43/PB/2018
• Status: Recruiting
• Phase: N/A
• Start date: August 25, 2018
• Est. completion date: December 31, 2019

Study information

• Verified date: December 2018
• Source: Maria Sklodowska-Curie Institute - Oncology Center
• Contact: Michal Filip Kaminski, MD, PhD
• Phone: +48 605438330
• Email: kaminski.mf[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 12298
• Est. completion date: December 31, 2019
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 55 Years to 64 Years

Eligibility

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.

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

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.
• 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.

Locations

Country	Name	City	State
Poland	Maria Sklodowska-Curie Institute - Oncology Center	Warsaw

Sponsors (3)

Lead Sponsor	Collaborator
Maria Sklodowska-Curie Institute - Oncology Center	Centre of Postgraduate Medical Education, Ministry of Health, Poland

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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