Clinical trial NCT05314309: Prospective Clinical Validation of a Novel Multitarget FIT in CRC Screening
Official title: 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 type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: CRC
Advanced Neoplasia
Lead sponsor: The Netherlands Cancer Institute
Sponsor class: OTHER
Collaborators: name: Amsterdam University Medical Centres (AUMC)
name: Erasmus Medical Center
First posted: 2022-04-06
Enrollment: 14712
Sex: ALL
Minimum age (years): 55
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The intended population of this study consists of subjects participating in the national Dutch National CRC screening program

Brief summary: The primary goal of the population-based colorectal (CRC) screening is early detection and interception of CRC and its precursors to decrease CRC-related morbidity and mortality. To improve current CRC screening programs, the investigators have developed and retrospectively validated a test that combines the detection of multiple proteins in stool (the multitarget faecal immunochemical test, mtFIT). mtFIT was found to have a higher accuracy to detect advanced neoplasia (AN), which includes CRC, advanced adenomas and advanced serrated polyps, in comparison to FIT. Thus, this multitarget test has the potential to improve the screening program's efficiency in reducing CRC-related incidence, morbidity and mortality. This new test, in comparison to FIT, shows specifically higher sensitivity in the detection of advanced adenomas, without affecting specificity.

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Detection rate of advanced neoplasia
timeFrame: 10 months
Secondary outcomes:
measure: Diagnostic yield of mtFIT in comparison to FIT
timeFrame: 10 months
Other outcomes:
measure: Long-term mtFIT efficacy
timeFrame: 10 months
Locations:
city: Amsterdam
country: Netherlands
facility: Netherlands Cancer Institute
Study officials:
affiliation: The Netherlands Cancer Institute
name: Gerrit A Meijer, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Amsterdam University Medical Centres (AUMC)
name: Evelien Dekker, MD, PhD
role: STUDY_CHAIR
affiliation: Erasmus University Medical Centre Rotterdam (Erasmus MC)
name: Manon CW Spaander, MD, PhD
role: STUDY_CHAIR
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