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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

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Biopsies

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "The final EXPOSE assay is expected to serve as a liquid biopsy-based tool for preoperative staging, enabling more precise identification of biologically advanced colon cancer cases."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study aims to develop a blood test to help judge how high-risk colon cancer is before surgery. It uses tiny bits of genetic material released by cancer cells and computer learning to build the test. It is for people with colon cancer who had surgery meant to remove all the cancer.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have stage I–IV colon cancer confirmed by testing tissue.
  • Had surgery meant to remove all the cancer, with or without other treatment around the time of surgery.
  • Have blood samples from before surgery available.
  • Have health records and information about how the cancer turned out available.

Who can't join

  • Did not give written consent to join the study.
  • Have no blood samples from before surgery.
  • Are missing records about survival or whether the cancer came back.
  • Are listed more than once in the study records.
  • Have a cancer type other than adenocarcinoma, which starts in gland cells.

Simplified for readability. The official criteria below are what the study team uses.

Official 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

Study sites (1)

CA