CI

At a glance

ClinicalIndex Comparison Record
N/ARecruiting· 2,000 target
Drug / intervention
DENEBother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT06342440
NCT06342440N/ARecruitingOn Track
Long Recruiting

A Liquid Biopsy Assay For The Non-Invasive Early Detection of Advanced Adenomas and Colorectal Cancer

City of Hope Medical Center·observational·Posted Apr 2, 2024·Updated Jun 17, 2026

In Brief

An observational study evaluating DENEB for Colorectal Cancer and 17 related conditions. Currently recruiting, targeting 2,000 participants across 6 sites in 5 countries.

Detailed 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.

Study Details

Timeline

N/ARecruitingOverdue
202120222023202420252026
First PostedApr 2, 2024
Enrollment StartMar 15, 2020
Primary CompletionJun 18, 2026
TodayJul 1, 2026
Enrollment to primary: 6.3 yearsPosted 2.2 years ago

Arms & Interventions

Non-disease controls (Discovery cohort)other

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

Low-risk Adenoma (Discovery cohort)other

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)other

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)other

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

Non-disease controls (Training cohort)other

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

Diagnostic Test: DENEB
Low-risk Adenoma (Training cohort)other

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.

Diagnostic Test: DENEB
Advanced Adenoma (Training cohort)other

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.

Diagnostic Test: DENEB
Colorectal Cancer (Training cohort)other

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

Diagnostic Test: DENEB
Non-disease controls (Validation cohort)other

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

Diagnostic Test: DENEB
Low-risk Adenoma (Validation cohort)other

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.

Diagnostic Test: DENEB
Advanced Adenoma (Validation cohort)other

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.

Diagnostic Test: DENEB
Colorectal Cancer (Validation cohort)other

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

Diagnostic Test: DENEB

Interventions

DENEBother

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