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

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ClinicalTrials.gov Identifier: NCT03790475
Recruitment Status : Unknown
Verified December 2018 by Michal F. Kaminski, MD, PhD, Maria Sklodowska-Curie National Research Institute of Oncology.
Recruitment status was:  Recruiting
First Posted : December 31, 2018
Last Update Posted : December 31, 2018
Sponsor:
Collaborators:
Ministry of Health, Poland
Centre of Postgraduate Medical Education
Information provided by (Responsible Party):
Michal F. Kaminski, MD, PhD, Maria Sklodowska-Curie National Research Institute of Oncology

Study Description
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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.


Condition or disease Intervention/treatment Phase
Colorectal Cancer Other: Offering a choice for colorectal cancer screening Other: Offering an alternative colorectal cancer screening method Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12298 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Participation In Competing Strategies for COLorectal Cancer screenINg - a randOmized Health Services Study Within the National Screening Program in Poland(PICCOLINO)
Actual Study Start Date : August 25, 2018
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Colonoscopy

Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. Completion of the assigned screening strategy within 18 weeks of enrollment [ Time Frame: 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 :
  1. Diagnostic yield for CRC and advanced adenomas [ Time Frame: Within 18 weeks of enrollment ]
    Advanced adenoma defined as adenoma >1 cm in size, or with high-grade dysplasia, or with villous component (>25%).


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   55 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03790475


Contacts
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Contact: Michal Filip Kaminski, MD, PhD +48 605438330 kaminski.mf@gmail.com
Contact: Nastazja Dagny Pilonis, MD +48 510291110 nastazja@gmail.com

Locations
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Poland
Maria Sklodowska-Curie Institute - Oncology Center Recruiting
Warsaw, Poland
Contact: Michal Filip Kaminski, MD, PhD    +48 605438330    mfkaminski@coi.waw.pl   
Contact: Nastazja Dagny Pilonis, MD    +48 510291110    nastazja@gmail.com   
Sponsors and Collaborators
Maria Sklodowska-Curie National Research Institute of Oncology
Ministry of Health, Poland
Centre of Postgraduate Medical Education
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Michal F. Kaminski, MD, PhD, MD, PhD, Maria Sklodowska-Curie National Research Institute of Oncology
ClinicalTrials.gov Identifier: NCT03790475    
Other Study ID Numbers: 43/PB/2018
First Posted: December 31, 2018    Key Record Dates
Last Update Posted: December 31, 2018
Last Verified: December 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Michal F. Kaminski, MD, PhD, Maria Sklodowska-Curie National Research Institute of Oncology:
Colorectal Cancer Screening
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
 Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases