Early Onset Colorectal Cancer Detection

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-50
SponsorCity of Hope Medical Center

About this trial

Colorectal cancer (CRC) once predominantly affected older individuals, but in recent years has witnessed a progressive increase in incidence among young adults. Once rare, early-onset colorectal cancer (EOCRC, that is, a CRC diagnosed before the age of 50) now constitutes 10-15% of all newly diagnosed CRC cases and it stands as the first cause of cancer-related death in young men and the second for young women.

This study aims to detect EOCRC with a non-invasive test, using a blood-based molecular assay based on microRNA (ribonucleic acid)

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Stage I, II, III, IV colorectal cancer (TNM classification, 8th edition) diagnosed before the age of 50 (EOCRC cases)

Received standard diagnostic and staging procedures as per local guidelines, and at least one sample was drawn before receiving any curative-intent treatment

Colonoscopy-proven cancer-free status at the time of study inclusion (Non-disease controls)

Disqualifiers

Hereditary colorectal cancer syndromes (identified through genetic testing)

Inflammatory bowel diseases

Lack of written informed consent

Trial population

Individuals younger than 50 years of age who were diagnosed with colorectal cancer before the age of 50 (cases) or were free from colorectal cancer at the time of study inclusion (controls)

Trial design

Design model

Case-control

Time perspective

Retrospective

Treatments tested in this trial

  • ENCODE

    Diagnostic test

    A panel of microRNA, both cell-free and exosomes, whose expression level is tested from plasma samples from patients with early onset colorectal cancer and non-disease controls.

Treatment groups

400 Participants
are divided into 4 treatment groups
Group A: Early onset colorectal cancer (Training cohort)1 intervention
Group B: Non-disease controls (Training cohort)1 intervention
Group C: Early onset colorectal cancer (Validation cohort)1 intervention
Group D: Non-disease controls (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 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

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