Colorectal CancerPICCOLINONCT03790475
Participation in Competing Strategies for Colorectal Cancer Screening - a Randomized Health Services Study Within the National Screening Program in Poland
A study testing Offering a choice for colorectal cancer screening and Offering an alternative colorectal cancer screening method in people with Colorectal Cancer, run by Maria Sklodowska-Curie National Research Institute of Oncology at 1 site in Poland.
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… Read more about this study
- Who is it for?
- Ages 55 to 64 years
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- Offering a choice for colorectal cancer screening and Offering an alternative colorectal cancer screening method
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12,298 participants
- Where
- 1 sitePoland
- Study dates
- 25 Aug 2018to 31 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Men and women aged 55 to 64 years residing in Poland and assigned to be invited to screening within the Polish Colonoscopy Screening Program .
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Poland1 site, 1 recruiting
- Recruiting
Maria Sklodowska-Curie Institute - Oncology Center
Warsaw
Michal Filip Kaminski, MD, PhD, +48 605438330, mfkaminski@coi.waw.pl
Nastazja Dagny Pilonis, MD, +48 510291110, nastazja@gmail.com
About this study
Official title: 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.
Read more
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.
- Conditions
- Colorectal Cancer
- Being tested
- Offering a choice for colorectal cancer screening, Offering an alternative colorectal cancer screening method
- Keywords
- Colorectal Cancer Screening
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Offering a choice for colorectal cancer screeningOther
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 methodOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Current screening practice. | No intervention | 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. |
| Sequential screening strategy. | Experimental | 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. Receives: Other: Offering an alternative colorectal cancer screening method |
| Multiple options screening strategy. | Experimental | 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. Receives: Other: Offering a choice for colorectal cancer screening |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Within 18 weeks of enrollment
Secondary outcomes (1)
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%).
Measured: Within 18 weeks of enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2018
- Study start25 Aug 2018
- Primary completion31 Dec 2019 (estimated)
- Study completion31 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 12,298 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Maria Sklodowska-Curie National Research Institute of Oncology
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, Poland, Centre of Postgraduate Medical Education
- Responsible party
- Principal investigator, Michal F. Kaminski, MD, PhD, Maria Sklodowska-Curie National Research Institute of Oncology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03790475
- Sponsor's protocol ID
- 43/PB/2018
- Acronym
- PICCOLINO
- Status last verified
- Dec 2018
- First submitted
- 21 Dec 2018
- Last updated
- 31 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 33307024
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Participation In Competing Strategies for COLorectal Cancer screenINg - a randOmized Health Services Study Within the National Screening Program in Poland(PICCOLINO)
- ClinicalTrials.gov ID
- NCT03790475
- Acronym / sponsor ID
- PICCOLINO / 43/PB/2018
- Conditions
- Colorectal Cancer
- Keywords
- Colorectal Cancer Screening
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12,298 participants (estimated)
- Lead sponsor
- Maria Sklodowska-Curie National Research Institute of OncologyUniversity, hospital or other
- Collaborators
- Ministry of Health, Poland, Centre of Postgraduate Medical Education
- Study start
- 25 Aug 2018 (actual)
- Primary completion
- 31 Dec 2019 (estimated)
- Study completion
- 31 Dec 2019 (estimated)
- First posted
- 31 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Current screening practice. | No intervention | –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. |
| Sequential screening strategy. | Experimental | Other: Offering an alternative colorectal cancer screening methodSubjects 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. |
| Multiple options screening strategy. | Experimental | Other: Offering a choice for colorectal cancer screeningSubjects 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. |
Who may qualify
- Ages
- 55 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Men and women aged 55 to 64 years residing in Poland and assigned to be invited to screening within the Polish Colonoscopy Screening Program .
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Offering a choice for colorectal cancer screeningPersons randomized to the multiple options screening strategy group will receive a postal invitation offering a choice between FIT and colonoscopy. | Other | Multiple options screening strategy. |
| Offering an alternative colorectal cancer screening methodPersons 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. | Other | Sequential screening strategy. |
Primary outcome
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.
1 secondary outcome
Diagnostic yield for CRC and advanced adenomas
Time frame: Within 18 weeks of enrollment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2018.
- Derived from this study: PubMed 33307024Pilonis 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Offering a choice for colorectal cancer screening and Offering an alternative colorectal cancer screening method in people with Colorectal Cancer, run by Maria Sklodowska-Curie National Research Institute of Oncology at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Michal Filip Kaminski, MD, PhD (+48 605438330, kaminski.mf@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Completion of the assigned screening strategy within 18 weeks of enrollment (time frame: Within 18 weeks of enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03790475, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Dec 2018.