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

NCT03462992 | Unknown

• 1 other identifier: MonoFIT+
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 1

Brief 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

Colorectal Cancer

Outcome Measures

Primary Outcomes (1)

• AUC of the MonoMark test

  Area Under the ROC Curve (AUC) of the MonoMark test, comparing its predictions to the colonoscopy-confirmed status.

  Within 1 year after recruitment completion.

Study Arms (1)

FIT-positive individuals

Patients being positive to an FIT test performed in the context of the Flemish (Northern Belgium) colorectal cancer screening campaign. These patients are male and female between 56 and 74 years old.

Diagnostic Test: MonoMark

Interventions

MonoMark DIAGNOSTIC_TEST

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.

FIT-positive individuals

Eligibility Criteria

• Age: 56 Years - 74 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Currently, a Flemish screening project is ongoing in male and female patients between 56 and 74 years old. If patients have a positive stool test, they are advised to contact their general practitioner for planning of a colonoscopy. The goal is to avoid 400 deaths of colon cancer per year. In 2013, 248.970 patients were invited of which 49% send a stool sample to the lab. Of all the examined tests, 10.1% tested positive. However, only 5 to 10% of patients testing positive with the stool test are diagnosed with cancer. Therefore, our goal is to discriminate with the monomark those patients with a high likelihood of having colon cancer. Patients of this study are patients who took part to this screening campaign and showed positive for the stool test.

You may qualify if:

• Having participated to the Flemish (Northern Belgium) Colorectal Screening Campaign and, as a result, having a positive stool test (FIT) outcome.

Sponsors & Collaborators

• DNAlytics: lead

Study Sites (1)

University Hospitals Leuven

Leuven, 3000, Belgium

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Hans Prenen, MD, PhD

  department of gastro-enterology, University Hospitals Leuven

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 5, 2018
• First Posted: March 13, 2018
• Study Start: December 11, 2012
• Primary Completion: December 21, 2017
• Study Completion: May 2, 2018
• Last Updated: March 13, 2018

Record last verified: 2018-03

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)