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RECRUITING
NCT07255729

An Exosomal microRNA Signature for Preoperative Staging in Colon Cancer

Sponsor: City of Hope Medical Center

View on ClinicalTrials.gov

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.

Official title: Machine Learning-Based Exosomal microRNA Signature for Preoperative Staging and Chemotherapy Eligibility in Colon Cancer

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

400

Start Date

2025-01-15

Completion Date

2026-06-18

Last Updated

2025-12-01

Healthy Volunteers

No

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)

Locations (1)

City of Hope Medical Center

Duarte, California, United States