Recruiting

Colorectal Cancer

Sponsor:

City of Hope Medical Center

Code:

NCT06342401

Conditions

Colorectal Cancer

Colorectal Neoplasms

Colorectal Adenocarcinoma

Colorectal Cancer Stage I

Colorectal Cancer Stage IV

Eligibility Criteria

Sex: All

Age: 18 - 50

Healthy Volunteers: Accepted

Interventions

ENCODE

Study Details

Brief summary:

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

Colorectal Cancer

Colorectal Neoplasms

Colorectal Adenocarcinoma

Colorectal Cancer Stage I

Colorectal Cancer Stage IV

Study ID

NCT06342401

Start date

Apr 15, 2023

Status verified date

Jul, 2026

Completion date

Jun 18, 2028

Anticipated

Primary completion date

Jun 18, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 50

Healthy Volunteers: Accepted

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

Enrollment

400 participants

Anticipated

Interventions and Outcome Measures

Arms

Early onset colorectal cancer (Training cohort)

Colorectal cancer diagnosed before the age of 50

Non-disease controls (Training cohort)

Individuals free from colorectal cancer, younger than 50 years of age

Early onset colorectal cancer (Validation cohort)

Colorectal cancer diagnosed before the age of 50

Non-disease controls (Validation cohort)

Individuals free from colorectal cancer, younger than 50 years of age

Interventions

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.

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Ajay Goel, PhD

626-218-3452AJGOEL@COH.ORG

Locations

City of Hope Medical Center

Recruiting

Duarte, California, United States, 91010

Contacts

Ajay Goel, PhD

626-218-3452AJGOEL@COH.ORG

Principal Investigator:

Alessandro Mannucci, MD

More Information

Sponsor

City of Hope Medical Center

Last update posted

Jul 7, 2026

Last verified

Jul, 2026

Keywords

  • Early onset
  • Young onset
  • Young adult
  • micro-RNA
  • Rectal cancer
  • Cancer of the young
  • Cancer detection
  • Liquid biopsy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by City of Hope Medical Center on 2026-07-07.