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

Inclusion Criteria4

  • Pathologically confirmed colon cancer (Stage I-IV, UICC TNM 8th edition)
  • Underwent curative-intent resection (with or without perioperative therapy)
  • Preoperative plasma (or serum) samples available
  • Clinical and prognostic data available

Exclusion Criteria5

  • No written informed consent
  • Missing preoperative blood samples
  • Missing survival/recurrence data
  • Duplicate cases
  • Non-adenocarcinoma histology

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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