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Prospective Clinical Validation of a Novel Multitarget FIT in CRC Screening

Active, not recruiting
Conditions
CRC
Advanced Neoplasia
Registration Number
NCT05314309
Lead Sponsor
The Netherlands Cancer Institute
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.

Recruitment & Eligibility

Status
ACTIVE_NOT_RECRUITING
Sex
All
Target Recruitment
14712
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 & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Detection rate of advanced neoplasia10 months

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.

Secondary Outcome Measures
NameTimeMethod
Diagnostic yield of mtFIT in comparison to FIT10 months

mtFIT detects more CRC, more early-stage CRC and more advanced polyps (advanced adenomas and advanced serrated polyps) compared to FIT.

Trial Locations

Locations (1)

Netherlands Cancer Institute

🇳🇱

Amsterdam, Netherlands

Netherlands Cancer Institute
🇳🇱Amsterdam, Netherlands

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