An Exosomal microRNA Signature for Preoperative Staging in Colon Cancer

ConditionColon Cancer
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorCity of Hope Medical Center

About this trial

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 criteria

Qualifiers

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

Disqualifiers

No written informed consent

Missing preoperative blood samples

Missing survival/recurrence data

Duplicate cases

Trial design

Treatments tested in this trial

  • Diagnostic Test: EXPOSE assay(Small RNA-seq of exosomal miRNAs)
  • Diagnostic Test: EXPOSE RT-qPCR panel

Treatment groups

400 Participants
are divided into 6 treatment groups

6

Treatment groups

See each treatment group below.

Sponsors and collaborators