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An Exosomal microRNA Signature for Preoperative Staging in Colon Cancer

NCT07255729 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 400

Last updated 2025-12-01

No results posted yet for this study

Summary

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.

Conditions

Interventions

DIAGNOSTIC_TEST

Diagnostic Test: EXPOSE assay（Small RNA-seq of exosomal miRNAs）

Candidates identified from small RNA sequencing

DIAGNOSTIC_TEST

Diagnostic Test: EXPOSE RT-qPCR panel

Quantification of exosomal microRNAs (RT-qPCR)

Sponsors & Collaborators

  • City of Hope Medical Center

    lead OTHER

Principal Investigators

  • Ajay Goel, PhD · City of Hope Medical Center

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-01-15
Primary Completion
2026-06-18
Completion
2026-06-18

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07255729 on ClinicalTrials.gov