RecruitingNCT07255729

An Exosomal microRNA Signature for Preoperative Staging in Colon Cancer

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


Sponsor

City of Hope Medical Center

Enrollment

400 participants

Start Date

Jan 15, 2025

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study collects blood samples from colon cancer patients before surgery to see whether tiny fragments of genetic material (called exosomal microRNA) found in the blood can be used to more accurately determine how advanced the cancer is — without the need for additional invasive procedures. **You may be eligible if...** - You have been diagnosed with colon cancer (any stage) - You underwent surgery with the goal of removing the cancer - You have pre-surgery blood samples that were stored - Your clinical information is available for research review **You may NOT be eligible if...** - You did not provide written informed consent for your data to be used - You do not have stored pre-surgical blood samples available Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

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

Candidates identified from small RNA sequencing

DIAGNOSTIC_TESTDiagnostic Test: EXPOSE RT-qPCR panel

Quantification of exosomal microRNAs (RT-qPCR)


Locations(1)

City of Hope Medical Center

Duarte, California, United States

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NCT07255729


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