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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
Who can join
Ages 18 and older · All sexes
Full eligibility criteria
Inclusion Criteria: * 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 Criteria: * No written informed consent * Missing preoperative blood samples * Missing survival/recurrence data * Duplicate cases * Non-adenocarcinoma histology
About the study
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.
What is being tested
- Diagnostic Test: EXPOSE assay（Small RNA-seq of exosomal miRNAs） (diagnostic test)
- Diagnostic Test: EXPOSE RT-qPCR panel (diagnostic test)
Sponsor: City of Hope Medical Center · Participants: 400 · Started: Jan 15, 2025
Contact the study team
- Ajay Goel, PhD · Phone: 626-218-3452
Official record on ClinicalTrials.gov — NCT07255729
Locations in the U.S.
| California | City of Hope Medical Center, Duarte |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.