Prospective Clinical Validation of a Novel Multitarget FIT in CRC Screening
NCT ID: NCT05314309
Last Updated: 2023-01-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
14712 participants
OBSERVATIONAL
2022-03-25
2023-05-31
Brief Summary
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Detailed Description
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The primary goal of population-based CRC screening is early detection and interception of CRC and its precursors to decrease CRC-related morbidity and mortality. New tests, with higher sensitivity for advanced precursor lesions than the current FIT, are desired. The investigators have developed a protein-based multitarget faecal immunochemical test (mtFIT) that shows higher sensitivity for advanced adenomas without losing in specificity.
Objective:
To prospectively validate the better performance of the mtFIT in comparison to FIT in the setting of a population-based CRC screening program.
Material and Methods:
In this prospective study, participants of the Dutch National CRC screening program (55-75 years of age) will be invited to participate. Individuals who consent to participate in the study, will be asked to take two stool samples from the same bowel movement. In a central laboratory these two samples then will be analyzed. One with the standard of care faecal immunochemical test (FIT) and the other with the multi-target faecal immunochemical test (mtFIT). If either one of these two tests is positive, individuals will be referred to undergo a colonoscopy procedure. The performance of mtFIT, in comparison to FIT, will be evaluated against the colonoscopy findings.
Expected results:
mtFIT has higher sensitivity for AN, and in particular advanced adenomas, than FIT, at equal positivity rate.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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mtFIT
Individuals who consent to participate in the study, will be asked to take two stool samples from the same bowel movement. In a central laboratory these two samples then will be analyzed. One with the standard of care faecal immunochemical test (FIT) and the other with the multi-target faecal immunochemical test (mtFIT). If either one of these two tests is positive, individuals will be referred to undergo a colonoscopy procedure. The performance of mtFIT, in comparison to FIT, will be evaluated against the colonoscopy findings.
Comparison of two tests (FIT and mtFIT) in the same bowel movement
Invitees for the Dutch National CRC screening program will be randomly selected by the Screening Organization and invited to participate in this study, where next to the current FIT, participants will also perform the mtFIT in one bowel movement. Both tests will be analysed and if one of the two test results is positive, the individual will be referred for colonoscopy.
Interventions
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Comparison of two tests (FIT and mtFIT) in the same bowel movement
Invitees for the Dutch National CRC screening program will be randomly selected by the Screening Organization and invited to participate in this study, where next to the current FIT, participants will also perform the mtFIT in one bowel movement. Both tests will be analysed and if one of the two test results is positive, the individual will be referred for colonoscopy.
Eligibility Criteria
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Inclusion Criteria
* The participants will be invited in phases and are selected out of different age groups.
* The selected participants will participate in the population CRC screening program for either the first, second, third or fourth time.
Exclusion Criteria
55 Years
75 Years
ALL
Yes
Sponsors
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Amsterdam University Medical Centers (UMC), Location Academic Medical Center (AMC)
OTHER
Erasmus Medical Center
OTHER
The Netherlands Cancer Institute
OTHER
Responsible Party
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Principal Investigators
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Gerrit A Meijer, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
The Netherlands Cancer Institute
Evelien Dekker, MD, PhD
Role: STUDY_CHAIR
Amsterdam University Medical Centers (UMC), Location Academic Medical Center (AMC)
Manon CW Spaander, MD, PhD
Role: STUDY_CHAIR
Erasmus University Medical Centre Rotterdam (Erasmus MC)
Locations
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Netherlands Cancer Institute
Amsterdam, , Netherlands
Countries
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References
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Wisse PHA, de Klaver W, van Wifferen F, van Maaren-Meijer FG, van Ingen HE, Meiqari L, Huitink I, Bierkens M, Lemmens M, Greuter MJE, van Leerdam ME, Spaander MCW, Dekker E, Coupe VMH, Carvalho B, de Wit M, Meijer GA. The multitarget faecal immunochemical test for improving stool-based colorectal cancer screening programmes: a Dutch population-based, paired-design, intervention study. Lancet Oncol. 2024 Mar;25(3):326-337. doi: 10.1016/S1470-2045(23)00651-4. Epub 2024 Feb 9.
Wisse PHA, de Klaver W, van Wifferen F, Meiqari L, Bierkens M, Greuter MJE, Carvalho B, van Leerdam ME, Spaander MCW, Dekker E, Coupe VMH, de Wit M, Meijer GA. The multitarget fecal immunochemical test versus the fecal immunochemical test for programmatic colorectal cancer screening: a cross-sectional intervention study with paired design. BMC Cancer. 2022 Dec 12;22(1):1299. doi: 10.1186/s12885-022-10372-2.
Other Identifiers
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1691110-204907-PG
Identifier Type: OTHER
Identifier Source: secondary_id
M22ANC
Identifier Type: -
Identifier Source: org_study_id
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