Recruiting

Colorectal Cancer

Sponsor:

City of Hope Medical Center

Code:

NCT06342440

Conditions

Colorectal Cancer

Colorectal Neoplasms

Colorectal Polyp

Colorectal Adenocarcinoma

Colorectal Disorders

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

DENEB

Study Details

Brief summary:

This study aims to develop a highly sensitive, specific, and cost-effective blood assay for early detection of colorectal adenomas and cancer, using advanced machine learning and state-of-the-art biological analyses.

Conditions

Colorectal Cancer

Colorectal Neoplasms

Colorectal Polyp

Colorectal Adenocarcinoma

Colorectal Disorders

Study ID

NCT06342440

Start date

Mar 15, 2020

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+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • 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.

Exclusion Criteria:

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

Study Design

Enrollment

2000 participants

Anticipated

Interventions and Outcome Measures

Arms

Non-disease controls (Discovery cohort)

Individuals who underwent colonoscopy and were found not to have any adenomas or cancer.

Low-risk Adenoma (Discovery cohort)

Individuals who underwent colonoscopy and were found to only have low-risk adenomas, defined as all of the following:

  • 1 to 4 adenomas at most.
  • All adenomas have low-grade dysplasia at most.
  • All adenomas are <10 mm in diameter

Advanced Adenoma (Discovery cohort)

Individuals who underwent colonoscopy and were found to have high-risk adenomas, defined as one or more of the following:

  • 5 or more adenomas.
  • One or more adenomas have high-grade dysplasia.
  • One or more adenomas are >10 mm in diameter

Colorectal Cancer (Discovery cohort)

Individuals who underwent colonoscopy and were found to have colorectal cancer.

Non-disease controls (Training cohort)

Individuals who underwent colonoscopy and were found not to have any adenomas or cancer.

Low-risk Adenoma (Training cohort)

Individuals who underwent colonoscopy and were found to only have low-risk adenomas, defined as:

  • 1 to 4 adenomas at most.
  • All adenomas have low-grade dysplasia at most.
  • All adenomas are <10 mm in diameter.

Advanced Adenoma (Training cohort)

Individuals who underwent colonoscopy and were found to have high-risk adenomas, defined as one or more of the following:

  • 5 or more adenomas.
  • One or more adenomas have high-grade dysplasia.
  • One or more adenomas are >10 mm in diameter.

Colorectal Cancer (Training cohort)

Individuals who underwent colonoscopy and were found to have colorectal cancer.

Non-disease controls (Validation cohort)

Individuals who underwent colonoscopy and were found not to have any adenomas or cancer.

Low-risk Adenoma (Validation cohort)

Individuals who underwent colonoscopy and were found to only have low-risk adenomas, defined as:

  • 1 to 4 adenomas at most.
  • All adenomas have low-grade dysplasia at most.
  • All adenomas are <10 mm in diameter.

Advanced Adenoma (Validation cohort)

Individuals who underwent colonoscopy and were found to have high-risk adenomas, defined as one or more of the following:

  • 5 or more adenomas.
  • One or more adenomas have high-grade dysplasia.
  • One or more adenomas are >10 mm in diameter.

Colorectal Cancer (Validation cohort)

Individuals who underwent colonoscopy and were found to have colorectal cancer.

Interventions

DENEB

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

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Ajay Goel, PhD

6262183452AJGOEL@COH.ORG

Locations

City of Hope Medical Center

Recruiting

Monrovia, California, United States, 91016

Contacts

Ajay Goel, PhD

626-218-3452AJGOEL@COH.ORG

Principal Investigator:

Ajay Goel, PhD

University of California San Diego

Recruiting

San Diego, California, United States, 92093

More Information

Sponsor

City of Hope Medical Center

Last update posted

Jul 7, 2026

Last verified

Jul, 2026

Keywords

  • Early detection
  • Micro RNA
  • miRNA
  • Liquid biopsy
  • Machine learning
  • Artificial Intelligence
  • Incidence
  • Polypectomy
  • Screening
  • Surveillance
  • Exosome
  • Vascicles

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.