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Purpose

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)

Conditions

Eligibility

Eligible Ages
Between 18 Years and 50 Years
Eligible Genders
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • 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)

Exclusion Criteria

  • Hereditary colorectal cancer syndromes (identified through genetic testing) - Inflammatory bowel diseases - Lack of written informed consent

Study Design

Phase
Study Type
Observational
Observational Model
Case-Control
Time Perspective
Retrospective

Arm Groups

ArmDescriptionAssigned Intervention
Early onset colorectal cancer (Training cohort) Colorectal cancer diagnosed before the age of 50
  • Diagnostic Test: ENCODE
    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.
    Other names:
    • ENCODE (Early oNset COlorectal cancer DEtection)
Non-disease controls (Training cohort) Individuals free from colorectal cancer, younger than 50 years of age
  • Diagnostic Test: ENCODE
    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.
    Other names:
    • ENCODE (Early oNset COlorectal cancer DEtection)
Early onset colorectal cancer (Validation cohort) Colorectal cancer diagnosed before the age of 50
  • Diagnostic Test: ENCODE
    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.
    Other names:
    • ENCODE (Early oNset COlorectal cancer DEtection)
Non-disease controls (Validation cohort) Individuals free from colorectal cancer, younger than 50 years of age
  • Diagnostic Test: ENCODE
    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.
    Other names:
    • ENCODE (Early oNset COlorectal cancer DEtection)

Recruiting Locations

More Details

Status
Recruiting
Sponsor
City of Hope Medical Center

Study Contact

Ajay Goel, PhD
626-218-3452
AJGOEL@COH.ORG

Detailed Description

The rising incidence of early-onset colorectal cancer (EOCRC) is a pressing clinical issue unique to our times, and it is expected to grow with an anticipated further 90% increase in incidence by the decade's end. Challenges persist even after reducing the CRC screening age to 45: under-45s lack routine screening and compliance in the 45-50 age group remains low, partly due to invasiveness and discomfort of standard screening methods. Urgent action is warranted to develop affordable, sensitive, and feasible screening for timely detection and improved participation. A non-invasive, patient-friendly screening test, like a blood-based assay, could address these epidemiological concerns and also attract underserved populations. This study involves the development and validation of a liquid biopsy, assessing circulating cell-free and exosomal microRNAs (cf-miRNA and exo-miRNA, respectively) for indirect sampling of tumor tissue in the bloodstream. The researchers intend to harness machine learning and bioinformatics to create an integrated panel (with both cf-miRNAs and exo-miRNAs) to enhance the inherently high sensitivity of cf-miRNAs with the distinctive specificity of exo-miRNAs. This combined approach will not only improve the performance of a diagnostic model but will also tap into the diverse tumor biology aspects of EOCRC. The study's core goal is to develop cost-efficient, non-invasive, clinic-friendly biomarkers with high sensitivity and specificity, aiding EOCRC detection. The researchers intend to do so in three phases: 1. To perform comprehensive small RNA-Seq from matched cf-miRNA, exo-miRNA, cancer-derived miRNA, and mucosa-derived miRNA. 2. To develop and train two miRNA detection panels (cf-miRNA and exo-miRNA, respectively) based on advanced machine-learning models and, then, combine these two using several machine-learning models to obtain a final detection biomarker. 3. To validate the findings in an independent cohort of EOCRC and controls. In summary, this proposal promises to improve patient care and compliance, and, ultimately, reduce mortality from EOCRC.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.