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Peripheral Blood Monocytes as Predictive Marker for Colorectal Cancer Diagnosis: A Comparative Study of a Stool Based Versus Blood Based Screening Test

NCT03462992 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 250

Last updated 2018-03-13

No results posted yet for this study

Summary

In this prospective study, the main goal is to evaluate the strength of Monomark -a monocyte-based transcriptomic test combined to a mathematical model- in patients with a positive FIT test. Therefore, in parallel to the routine FIT screening, blood samples will be harvested and the monocyte genetic profile will be determined. This fundamental study, will disclose the diagnostic power of a biomarker panel ("MonoMark") head to head with the well-established FIT diagnostic test, a core prerequisite for the routine use of this test as an alternative and more reliable CRC screening tool.

Conditions

Interventions

DIAGNOSTIC_TEST

MonoMark

MonoMark (also known under the registered trademark ColonoKit), is a monocyte-based test using a transcriptomic signature and a mathematical predictive model aimed at discriminating between healthy individuals and CRC patients.

Sponsors & Collaborators

  • DNAlytics

    lead INDUSTRY

Principal Investigators

  • Hans Prenen, MD, PhD · department of gastro-enterology, University Hospitals Leuven

Eligibility

Min Age
56 Years
Max Age
74 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-12-11
Primary Completion
2017-12-21
Completion
2018-05-02

Countries

  • Belgium

Study Locations

More Related Trials

Entities

Diseases

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 NCT03462992 on ClinicalTrials.gov