Colorectal CancerColorectal NeoplasmsColorectal PolypColorectal AdenocarcinomaColorectal DisordersColorectal DysplasiaColorectal Cancer Stage IColorectal Cancer Stage IIColorectal Cancer Stage IIIColorectal Cancer Stage IVColorectal Neoplasms MalignantColorectal Serrated AdenocarcinomaColorectal Adenoma With Severe DysplasiaColorectal Adenoma With Mild DysplasiaColorectal Adenoma With Moderate DysplasiaColorectal Adenoma and Carcinoma 1Colorectal Adenomatous PolypColorectal Adenocarcinoma Metastatic in the Liver
Investigational drug(s) / intervention(s)
DENEB
DENEB: A panel of circulating microRNA, whose expression level is tested in cell-free and exosome-derived samples.
Study summary
This study aims to develop a highly sensitive, specific, and cost-effective blood assay for early detection of colorectal adenomas and cancer, using advanced machine learning and state-of-the-art biological analyses.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
Accepted
Inclusion Criteria:
* All individuals included in the study need to have had a colonoscopy at the time of blood sampling.
* Received standard diagnostic and staging (as necessary) procedures as per local guidelines, and at least one sample was drawn before receiving any curative-intent treatment.
* Received standard pathological and endoscopic diagnosis and assessment for cohort assignment.
Exclusion Criteria:
* Hereditary colorectal cancer syndromes (identified through genetic testing).
* Inflammatory bowel diseases.
* Lack of written informed consent.
Primary outcome measure(s)
Sensitivity — Through study completion, an average of 1 year True positive rate: the probability of a positive test result, conditioned on the individual truly being positive
Trial sites (6)
Facility
City
Region
Status
City of Hope Medical Center
Monrovia
California
Recruiting
University of California San Diego
San Diego
California
Recruiting
The First Affiliated Hospital of Dalian Medical University
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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