CRCmtFITNCT05314309
Prospective Clinical Validation of a Novel Multitarget FIT in CRC Screening
An observational study of CRC and Advanced Neoplasia, run by The Netherlands Cancer Institute at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 55 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- CRC, Advanced Neoplasia
- What is being tested?
- Comparison of two tests (FIT and mtFIT) in the same bowel movement
- How many people
- 14,712 participants
- Where
- 1 siteNetherlands
- Study dates
- 25 Mar 2022to 31 May 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The intended population of this study consists of subjects participating in the national Dutch National CRC screening program
Who may be able to join
- 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.
Who cannot join
- Collection of stool not complete for both tests (FIT and mtFIT)
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- CRC, Advanced Neoplasia
- Being tested
- Comparison of two tests (FIT and mtFIT) in the same bowel movement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Comparison of two tests (FIT and mtFIT) in the same bowel movementDiagnostic test
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: Comparison of two tests (FIT and mtFIT) in the same bowel movement |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 10 months
Secondary outcomes (1)
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.
Measured: 10 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2022
- Study start25 Mar 2022
- Primary completion31 May 2023 (estimated)
- Study completion31 May 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for CRCStudies of the same condition, open and under way.
- More trials run by The Netherlands Cancer InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 14,712 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Netherlands Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Amsterdam University Medical Centers (UMC), Location Academic Medical Center (AMC), Erasmus Medical Center
- Responsible party
- Sponsor
- Investigators
- Gerrit A Meijer, MD, PhD, Principal investigator, The Netherlands Cancer InstituteEvelien Dekker, MD, PhD, Study chair, Amsterdam University Medical Centers (UMC), Location Academic Medical Center (AMC)Manon CW Spaander, MD, PhD, Study chair, Erasmus University Medical Centre Rotterdam (Erasmus MC)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05314309
- Sponsor's protocol ID
- M22ANC
- Other IDs
- 1691110-204907-PG
- Acronym
- mtFIT
- Status last verified
- Jan 2023
- First submitted
- 14 Feb 2022
- Last updated
- 11 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 38346438Wisse 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.
PubMed 36503495
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05314309
- Acronym / sponsor ID
- mtFIT / M22ANC
- Conditions
- CRC, Advanced Neoplasia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 14,712 participants (actual)
- Lead sponsor
- The Netherlands Cancer InstituteUniversity, hospital or other
- Collaborators
- Amsterdam University Medical Centers (UMC), Location Academic Medical Center (AMC), Erasmus Medical Center
- Study start
- 25 Mar 2022 (actual)
- Primary completion
- 31 May 2023 (estimated)
- Study completion
- 31 May 2023 (estimated)
- First posted
- 6 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| mtFIT | – | Diagnostic Test: Comparison of two tests (FIT and mtFIT) in the same bowel movementIndividuals 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. |
Who may qualify
- Ages
- 55 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The intended population of this study consists of subjects participating in the national Dutch National CRC screening program
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- Collection of stool not complete for both tests (FIT and mtFIT)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Comparison of two tests (FIT and mtFIT) in the same bowel movementInvitees 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. | Diagnostic test | mtFIT |
Primary outcome
Detection rate of advanced neoplasia
Time frame: 10 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.
1 secondary outcome
Diagnostic yield of mtFIT in comparison to FIT
Time frame: 10 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2023.
- Derived from this study: PubMed 38346438Wisse 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.
- Derived from this study: PubMed 36503495Wisse 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gerrit A Meijer, MD, PhD principal investigator
The Netherlands Cancer Institute
Evelien Dekker, MD, PhD study chair
Amsterdam University Medical Centers (UMC), Location Academic Medical Center (AMC)
Manon CW Spaander, MD, PhD study chair
Erasmus University Medical Centre Rotterdam (Erasmus MC)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of CRC and Advanced Neoplasia, run by The Netherlands Cancer Institute at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Detection rate of advanced neoplasia (time frame: 10 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05314309, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jan 2023.