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

First listed
Apr 2, 2024
Start date
Mar 15, 2020
Status verified
Jul 2026
Primary completion
Jun 18, 2028
Completion
Jun 18, 2028

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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