An observational study in CRC and Advanced Neoplasia, sponsored by The Netherlands Cancer Institute. Status unknown at 1 site in Netherlands. Open to participants aged 55 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-01-11.
Sponsored by The Netherlands Cancer Institute · Observational
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.
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.
9,365 studies on the registry are indexed under Neoplasms; 2,489 are open to participants now.
This study's enrollment of 14,712 is above the median of 204 across 1,683 observational studies indexed under Neoplasms.
Browse Neoplasms studies →The Netherlands Cancer Institute is the lead sponsor of 224 studies on the registry; 66 are open to participants now.
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The intended population of this study consists of subjects participating in the national Dutch National CRC screening program
Exclusion Criteria:
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.
Diagnostic Test: 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.
Detection rate of advanced neoplasia
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.
Time frame: 10 months
Diagnostic yield of mtFIT in comparison to FIT
mtFIT detects more CRC, more early-stage CRC and more advanced polyps (advanced adenomas and advanced serrated polyps) compared to FIT.
Time frame: 10 months
Long-term mtFIT efficacy
mtFIT reduces CRC incidence and CRC-related mortality compared to FIT and is cost-effective to be used in a CRC screening program.
Time frame: 10 months
Plan to share: No
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This study is status unknown, as verified in Jan 2023. You cannot join it, but the record below documents what was studied.
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The Netherlands Cancer Institute