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 volunteersQualifiers
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
Case-control
Prospective
Treatments tested in this trial
ONCOSCREEN
Diagnostic testSubjects samples will be tested with diagnostic tests.
Treatment groups
Trial outcomes
Primary outcomes
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.
ONCO NMR expression pattern
Blood samples will be collected to assess various novel biomarkers associated with CRC.
ONCO CRISPR expression pattern
Blood and stool samples will be collected to assess various novel biomarkers associated with CRC.
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.
Sponsors and contacts
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Firalis SA
Lead sponsor
University Medical Center Mainz
Collaborator