Early Detection of Colorectal Cancer and Advanced Adenomas

This observational study is looking for 2000 participants to help develop a new blood test called DENEB. DENEB is a diagnostic test that examines tiny genetic materials (circulating microRNA) in your blood to find early signs of colorectal adenomas (pre-cancerous growths) and colorectal cancer. The goal is to create a highly accurate and affordable blood test that can detect these conditions early. To join, you must be 18 or older, have had a colonoscopy at the time of your blood sample, and received standard diagnoses. The study will measure how well DENEB can detect these conditions (sensitivity) over about one year. The current status of this study is unclear.

Study design
This is an observational study aiming to enroll 2000 participants. It is not a treatment study but focuses on developing a diagnostic test.
What's involved
You must have had a colonoscopy when your blood sample was taken. You also need to have received standard diagnostic and staging procedures.
Compensation
Not stated in the trial record.
Follow-up
The study will measure sensitivity through study completion, which is an average of one year.

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NCT06342440

Early Detection of Advanced Adenomas and Colorectal Cancer

Recruiting
Not specifiedAges 18+Observational
City of Hope Medical Center
~2,000 participants
Updated 2026-07-07 on ClinicalTrials.gov
What's tested:DENEB

At a glance

Recruiting sites
6 of 6 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Sensitivity
Measured over Through study completion, an average of 1 year
Colorectal Cancer
Colorectal Neoplasms
Colorectal Polyp
Colorectal Adenocarcinoma
Colorectal Disorders
Colorectal Dysplasia
Colorectal Cancer Stage I
Colorectal Cancer Stage II
Colorectal Cancer Stage III
Colorectal Cancer Stage IV
Colorectal Neoplasms Malignant
Colorectal Serrated Adenocarcinoma
Colorectal Adenoma With Severe Dysplasia
Colorectal Adenoma With Mild Dysplasia
Colorectal Adenoma With Moderate Dysplasia
Colorectal Adenoma and Carcinoma 1
Colorectal Adenomatous Polyp
Colorectal Adenocarcinoma Metastatic in the Liver
6 sites across 5 states
California2
China1
Italy1
Japan1
Spain1
  • Ajay Goel, PhD · PRINCIPAL_INVESTIGATOR · City of Hope Medical Center

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Eligibility criteria

Inclusion

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

Hereditary colorectal cancer syndromes (identified through genetic testing).
Inflammatory bowel diseases.
Lack of written informed consent.
  • SensitivityThrough study completion, an average of 1 year

    True positive rate: the probability of a positive test result, conditioned on the individual truly being positive