An Exosomal microRNA Signature for Preoperative Staging in Colon Cancer

Part of paid clinical trials in Duarte, California.

Sponsor
City of Hope Medical Center
Study ID
NCT07255729
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Diagnostic Test: EXPOSE assay（Small RNA-seq of exosomal miRNAs） — DIAGNOSTIC_TEST
    Candidates identified from small RNA sequencing
  • Diagnostic Test: EXPOSE RT-qPCR panel — DIAGNOSTIC_TEST
    Quantification of exosomal microRNAs (RT-qPCR)

Study Details

Recent studies have highlighted the potential benefits of neoadjuvant chemotherapy (NAC) in colon cancer; however, its indication is generally limited to cases corresponding to pathological stage IIB or higher. Accurately identifying such high-risk cases before surgery remains challenging using conventional clinical diagnostics alone. Therefore, we hypothesized that integrating molecular biomarkers with preoperative clinical assessment could provide a more precise and sensitive evaluation of tumor aggressiveness. In this context, we focused on exosomal microRNAs, which are actively secreted from tumor cells and remain stable in circulation, and aimed to develop a machine learning-based biomarker panel. To achieve this, we initiated a multicenter study utilizing preoperative plasma samples to establish a reliable biomarker model for risk stratification and treatment decision-making in colon cancer.

Key Dates

Start date
Jan 15, 2025
Status verified
Nov 2025
Primary completion
Jun 18, 2026
Completion
Jun 18, 2026

Study Design

Enrollment
400 participants (estimated)

Arms

  • Arm: High-risk Colon Cancer (Discovery)
    Stage IIB-IV colon cancer; used to identify biomarker candidates
  • Arm: Low-risk Colon Cancer (Discovery)
    Stage I-IIA colon cancer
  • Arm: High-risk Colon Cancer (Training)
    Pathological Stage IIB-IV; used to build model
  • Arm: Low-risk Colon Cancer (Training)
    Pathological Stage I-IIA
  • Arm: High-risk Colon Cancer (Validation)
    Stage IIB-IV in independent cohort
  • Arm: Low-risk Colon Cancer (Validation)
    Stage I-IIA in independent cohort

Primary Outcome Measure

Pathological Stage IIB or higher patients [ Time Frame: At time of pathology (1year after surgery) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
City of Hope Medical CenterDuarteCalifornia91016
Ajay Goel, PhD
[email protected]
626-218-3452

Find similar trials in Duarte, CA

By condition
Colorectal cancer
By specialty
OncologyGI oncology
By research site
City of Hope Medical Center· Duarte, CA

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