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Prospective Clinical Validation of a Novel Multitarget FIT in CRC Screening

NCT05314309 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 14712

Last updated 2023-01-11

No results posted yet for this study

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.

Conditions

  • CRC
  • Advanced Neoplasia

Interventions

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.

Sponsors & Collaborators

  • Amsterdam University Medical Centers (UMC), Location Academic Medical Center (AMC)

    collaborator OTHER

  • Erasmus Medical Center

    collaborator OTHER

  • The Netherlands Cancer Institute

    lead OTHER

Principal Investigators

  • Gerrit A Meijer, MD, PhD · The Netherlands Cancer Institute

  • Evelien Dekker, MD, PhD · Amsterdam University Medical Centers (UMC), Location Academic Medical Center (AMC)

  • Manon CW Spaander, MD, PhD · Erasmus University Medical Centre Rotterdam (Erasmus MC)

Eligibility

Min Age
55 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-03-25
Primary Completion
2023-05-31
Completion
2023-05-31

Countries

  • Netherlands

Study Locations

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Diseases
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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05314309 on ClinicalTrials.gov