Early Onset Colorectal Cancer Detection

Part of paid clinical trials in Duarte, California.

Sponsor
City of Hope Medical Center
Study ID
NCT06342401
Status
Recruiting

Conditions

  • Colorectal Adenocarcinoma
  • Colorectal Cancer
  • Colorectal Cancer Stage I
  • Colorectal Cancer Stage II
  • Colorectal Cancer Stage III
  • Colorectal Cancer Stage IV
  • Colorectal Neoplasms
  • Colorectal Neoplasms Malignant

Eligibility Criteria

Sex
ALL
Age
18 Years - 50 Years
Healthy Volunteers
Accepted

Interventions

  • 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.

Study Details

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)

Key Dates

Start date
Apr 15, 2023
Status verified
Jan 2026
Primary completion
Jun 18, 2026
Completion
Jun 18, 2026

Study Design

Enrollment
400 participants (estimated)

Arms

  • Arm: Early onset colorectal cancer (Training cohort)
    Colorectal cancer diagnosed before the age of 50
  • Arm: Non-disease controls (Training cohort)
    Individuals free from colorectal cancer, younger than 50 years of age
  • Arm: Early onset colorectal cancer (Validation cohort)
    Colorectal cancer diagnosed before the age of 50
  • Arm: Non-disease controls (Validation cohort)
    Individuals free from colorectal cancer, younger than 50 years of age

Primary Outcome Measure

Sensitivity [ Time Frame: Through study completion, an average of 1 year ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
City of Hope Medical CenterDuarteCalifornia91010
Ajay Goel, PhD
626-218-3452
Alessandro Mannucci, MD (PRINCIPAL_INVESTIGATOR)

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