Early Detection of Advanced Adenomas and Colorectal Cancer

Part of paid clinical trials in Monrovia, California.

Sponsor
City of Hope Medical Center
Study ID
NCT06342440
Status
Recruiting
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Conditions

  • Colorectal Adenocarcinoma
  • Colorectal Adenocarcinoma Metastatic in the Liver
  • Colorectal Adenoma With Mild Dysplasia
  • Colorectal Adenoma With Moderate Dysplasia
  • Colorectal Adenoma With Severe Dysplasia
  • Colorectal Adenoma and Carcinoma 1
  • Colorectal Adenomatous Polyp
  • Colorectal Cancer
  • Colorectal Cancer Stage I
  • Colorectal Cancer Stage II
  • Colorectal Cancer Stage III
  • Colorectal Cancer Stage IV
  • Colorectal Disorders
  • Colorectal Dysplasia
  • Colorectal Neoplasms
  • Colorectal Neoplasms Malignant
  • Colorectal Polyp
  • Colorectal Serrated Adenocarcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Mar 15, 2020
Status verified
Jun 2025
Primary completion
Jun 18, 2026
Completion
Jun 18, 2026

Study Design

Enrollment
2,000 participants (estimated)

Arms

  • Arm: Non-disease controls (Discovery cohort)
    Individuals who underwent colonoscopy and were found not to have any adenomas or cancer.
  • Arm: 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
  • Arm: 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
  • Arm: Colorectal Cancer (Discovery cohort)
    Individuals who underwent colonoscopy and were found to have colorectal cancer.
  • Arm: Non-disease controls (Training cohort)
    Individuals who underwent colonoscopy and were found not to have any adenomas or cancer.
  • Arm: 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.
  • Arm: 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.
  • Arm: Colorectal Cancer (Training cohort)
    Individuals who underwent colonoscopy and were found to have colorectal cancer.
  • Arm: Non-disease controls (Validation cohort)
    Individuals who underwent colonoscopy and were found not to have any adenomas or cancer.
  • Arm: 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.
  • Arm: 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.
  • Arm: Colorectal Cancer (Validation cohort)
    Individuals who underwent colonoscopy and were found to have colorectal cancer.

Primary Outcome Measure

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

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
City of Hope Medical CenterMonroviaCalifornia91016
Ajay Goel, PhD
[email protected]
626-218-3452
Ajay Goel, PhD (PRINCIPAL_INVESTIGATOR)
Caiming Xu (SUB_INVESTIGATOR)
Alessandro Mannucci (SUB_INVESTIGATOR)
James Lin (SUB_INVESTIGATOR)
Gregory Idos (SUB_INVESTIGATOR)
Trilokesh Kadambi (SUB_INVESTIGATOR)
University of California San DiegoSan DiegoCalifornia92093
C Richard Boland, MD, PhD
C Richard Boland, MD, PhD (SUB_INVESTIGATOR)

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City of Hope Medical Center· Monrovia, CAUniversity of California San Diego· San Diego, CA

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