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Liquid Biopsy and Machine Learning for Early Colorectal Cancer, Adenomas, Lynch Cancers, and Residual Disease Detection

ConditionsColorectal CancerAdenoma ColonAdenoma Colon PolypColon AdenomaColo-rectal CancerColon DiseaseColon NeoplasmLynch SyndromeLynch Syndrome ILynch Syndrome IILynch Syndrome I (Site-specific Colonic Cancer)LYN Gene MutationMismatch Repair DeficiencyMismatch Repair Gene MutationMLH1 Gene MutationMSH2 Gene MutationMSH6 Gene MutationPMS2 Gene MutationEPCAM Gene Mutation
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorSan Raffaele University

About this trial

This is an multicenter study that will test the diagnostic accuracy of a blood test (i.e., a liquid biopsy) for the diagnosis of colorectal cancer (CRC), advanced adenomas (AAs), as well as Lynch-syndrome associated cancers. Additionally, a pre-planned analysis will evaluate the use of this liquid biopsy as a tool for molecular residual disease monitoring purposes.

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

Lack of informed consent

Inflammatory bowel disease

Trial population

Seven independent cohorts of individuals who belong to one of the following seven: * Lynch syndrome, without any Lynch-syndrome-associated cancer * Lynch syndrome, with one or more Lynch-syndrome-associated cancer(s) * Sporadic colorectal cancer * Sporadic advanced adenoma (at most) * Colonoscopy-negative controls * Treatment-naive blood samples * Post-treatment blood samples

Trial design

Design model

Case-control

Time perspective

Retrospective

Treatments tested in this trial

  • BEACON

    Diagnostic test

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

Treatment groups

1,200 Participants
are divided into 7 treatment groups

7

Treatment groups

See each treatment group below.

Group A: Lynch syndrome, without Lynch-syndrome associated cancers1 intervention
Group B: Lynch syndrome, with Lynch-syndrome associated cancers1 intervention
Group C: Colorectal cancer1 intervention
Group D: Advanced adenoma1 intervention
Group E: Colonoscopy-negative controls1 intervention
Group F: Pre-treatment samples1 intervention
Group G: Post-treatment samples1 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.

San Raffaele University

Lead sponsor

Source ClinicalTrials.gov
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