- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05314309
Prospective Clinical Validation of a Novel Multitarget FIT in CRC Screening (mtFIT)
Clinical Validation of a Multi-target Faecal Immunochemical Test (mtFIT) Versus a Faecal Immunochemical Test (FIT) for Detecting Advanced Neoplasia in Population Screening for CRC: a Prospective Cohort Study With Paired Design
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Background:
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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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-
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Amsterdam, Netherlands
- Netherlands Cancer Institute
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Individuals of the Dutch population suitable for CRC screening (age between 55 and 75 years old) will be randomly selected.
- 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:
- Collection of stool not complete for both tests (FIT and mtFIT)
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
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.
|
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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Detection rate of advanced neoplasia
Time Frame: 10 months
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Relative sensitivity of mtFIT compared to FIT in the detection of advanced neoplasia (AN; CRC, advanced adenomas and advanced serrated polyps) at an equal positivity rate.
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10 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Diagnostic yield of mtFIT in comparison to FIT
Time Frame: 10 months
|
mtFIT detects more CRC, more early-stage CRC and more advanced polyps (advanced adenomas and advanced serrated polyps) compared to FIT.
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10 months
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Long-term mtFIT efficacy
Time Frame: 10 months
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mtFIT reduces CRC incidence and CRC-related mortality compared to FIT and is cost-effective to be used in a CRC screening program.
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10 months
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Gerrit A Meijer, MD, PhD, The Netherlands Cancer Institute
- Study Chair: Evelien Dekker, MD, PhD, Amsterdam University Medical Centres (AUMC)
- Study Chair: Manon CW Spaander, MD, PhD, Erasmus University Medical Centre Rotterdam (Erasmus MC)
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- M22ANC
- 1691110-204907-PG (Other Identifier: Dutch Ministry of Health, Welfare and Sport (VWS))
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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