Multicentre Study for Data Collection, Development, and Evaluation of Novel CRC Screening and Diagnostic Methods

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorFiralis SA

About this trial

The primary goal is to develop easy accessible diagnostic tools for high risk subjects for colon cancer in different European populations to improve early CRC detection. These CRC screening technologies would be low cost, breakthrough and of high sensitivity and specificity.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

CRC Group

Signature of the informed consent indicating that the subject accepts to participate in the study and to comply with the requirements and restrictions inherent in this study.

Subjects aged ≥18 years

Subject is willing to undergo FOBT test, colonoscopy, and tissue biopsy

Disqualifiers

For the CRC Group

Legal incapacity or limited legal capacity

Subject did not sign the Informed Consent form

Subject who, according to the investigator's assessment, presents with an unstable medical condition contraindicating the performance of the planned blood test, stool test or breath test

Trial population

Subjects aged over 18 for all groups except the control group with no risk where in this group subjects are aged ≥ 40 years.

Trial design

Design model

Case-control

Time perspective

Prospective

Treatments tested in this trial

  • ONCOSCREEN

    Diagnostic test

    Subjects samples will be tested with diagnostic tests.

Treatment groups

4,100 Participants
are divided into 4 treatment groups
Group A: CRC Group1 intervention
Group B: Control Group with risks and presence of polyps1 intervention
Group C: Control Group with risks and absence of polyps1 intervention
Group D: Control Group with no risks1 intervention

Trial outcomes

Primary outcomes

1

ONCO CTC expression pattern of ONCOSCREEN tools in CRC patients and healthy controls using colonoscopy as the reference method.

Blood samples will be collected to assess various novel biomarkers associated with CRC.

Time frame
At the day of visit/sampling and through study completion, an average of 3 years
2

ONCO NMR expression pattern

Blood samples will be collected to assess various novel biomarkers associated with CRC.

Time frame
At Day1 and through study completion, an average of 3 years
3

ONCO CRISPR expression pattern

Blood and stool samples will be collected to assess various novel biomarkers associated with CRC.

Time frame
At Day1 and through study completion, an average of 3 years
4

ONCO VOC expression pattern

Breath samples will be collected to analyze volatile organic compounds (VOCs). By examining the electrochemical signal responses using pattern recognition algorithms, researchers can identify early indicators distinguishing between CRC-linked and healthy categories.

Time frame
At Day1 and through study completion, an average of 3 years

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Firalis SA

Lead sponsor

University Medical Center Mainz

Collaborator