Early Detection of Advanced Adenomas and Colorectal Cancer

NCT06342440 | Recruiting

• 1 other identifier: 23228/AACRC
• Study Type: observational
• Target: 2,000
• Locations: 5 countries
• Sites: 6

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; 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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Sensitivity

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

  Through study completion, an average of 1 year

Secondary Outcomes (2)

• Specificity

  Through study completion, an average of 1 year

• Proportion of correct predictions (true positives and true negatives) among the total number of cases (i.e., accuracy)

  Through study completion, an average of 1 year

Study Arms (12)

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.

Diagnostic Test: DENEB

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.

Diagnostic Test: DENEB

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.

Diagnostic Test: DENEB

Colorectal Cancer (Training cohort)

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

Diagnostic Test: DENEB

Non-disease controls (Validation cohort)

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

Diagnostic Test: DENEB

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.

Diagnostic Test: DENEB

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.

Diagnostic Test: DENEB

Colorectal Cancer (Validation cohort)

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

Diagnostic Test: DENEB

Interventions

DENEB DIAGNOSTIC_TEST

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

Also known as: DENEB (DEtection of colorectal NEoplasias in Blood)

Advanced Adenoma (Training cohort); Advanced Adenoma (Validation cohort); Colorectal Cancer (Training cohort); Colorectal Cancer (Validation cohort); Low-risk Adenoma (Training cohort); Low-risk Adenoma (Validation cohort); Non-disease controls (Training cohort); Non-disease controls (Validation cohort)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Three independent cohorts of individuals who belong to one of the following four * Negative colonoscopy findings * Low-risk adenomas (at most) * Advanced adenomas (at most) * Colorectal cancer

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• City of Hope Medical Center: lead

Study Sites (6)

City of Hope Medical Center

Monrovia, California, 91016, United States

RECRUITING

University of California San Diego

San Diego, California, 92093, United States

RECRUITING

The First Affiliated Hospital of Dalian Medical University

Dalian, China

RECRUITING

IRCCS San Raffaele

Milan, Italy

RECRUITING

Mie University

Mie, Japan

RECRUITING

Barcelona University

Barcelona, Spain

RECRUITING

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Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum

MeSH Terms

Conditions

Colorectal Neoplasms; Colonic Neoplasms; Polyposis Syndrome, Hereditary Mixed, 1

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Ajay Goel, PhD

  City of Hope Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ajay Goel, PhD

CONTACT

6262183452; AJGOEL@COH.ORG

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 26, 2024
• First Posted: April 2, 2024
• Study Start: March 15, 2020
• Primary Completion (Estimated): June 18, 2026
• Study Completion (Estimated): June 18, 2026
• Last Updated: June 17, 2025

Record last verified: 2025-06

Locations

IT (1); ES (1); JP (1); CN (1); US (2)