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Early Detection of Advanced Adenomas and Colorectal Cancer

ConditionsColorectal 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
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorCity of Hope Medical Center

About this trial

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 criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

Hereditary colorectal cancer syndromes (identified through genetic testing).

Inflammatory bowel diseases.

Lack of written informed consent.

Trial population

Three independent cohorts of individuals who belong to one of the following four * Negative colonoscopy findings * Low-risk adenomas (at most) * Advanced adenomas (at most) * Colorectal cancer

Trial design

Design model

Case-control

Time perspective

Retrospective

Treatments tested in this trial

  • DENEB

    Diagnostic test

    A panel of circulating microRNA, whose expression level is tested in cell-free and exosome-derived samples.

Treatment groups

2,000 Participants
are divided into 12 treatment groups

12

Treatment groups

See each treatment group below.

Group A: Non-disease controls (Discovery cohort)0 interventions
Group B: Low-risk Adenoma (Discovery cohort)0 interventions
Group C: Advanced Adenoma (Discovery cohort)0 interventions
Group D: Colorectal Cancer (Discovery cohort)0 interventions
Group E: Non-disease controls (Training cohort)1 intervention
Group F: Low-risk Adenoma (Training cohort)1 intervention
Group G: Advanced Adenoma (Training cohort)1 intervention
Group H: Colorectal Cancer (Training cohort)1 intervention
Group I: Non-disease controls (Validation cohort)1 intervention
Group J: Low-risk Adenoma (Validation cohort)1 intervention
Group K: Advanced Adenoma (Validation cohort)1 intervention
Group L: Colorectal Cancer (Validation cohort)1 intervention

Trial outcomes

Primary outcomes

1

Sensitivity

True positive rate: the probability of a positive test result, conditioned on the individual truly being positive

Time frame
Through study completion, an average of 1 year

Secondary outcomes

1

Specificity

True negative rate: the probability of a negative test result, conditioned on the individual truly being negative

Time frame
Through study completion, an average of 1 year
2

Proportion of correct predictions (true positives and true negatives) among the total number of cases (i.e., accuracy)

A measure of trueness: proportion of correct predictions (both true positives and true negatives) among the total number of cases examined

Time frame
Through study completion, an average of 1 year

Other outcomes

Sponsors and contacts

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

City of Hope Medical Center

Lead sponsor

Source ClinicalTrials.gov
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