Blood test of exosomal microRNAs to stage colon cancer before surgery
Official title: Machine Learning-Based Exosomal microRNA Signature for Preoperative Staging and Chemotherapy Eligibility in Colon Cancer
Run by City of Hope Medical Center · NCT07255729 · Data updated 2026-11-12
This project will try a blood test that measures tumor-released exosomal microRNAs to see if it can identify patients with higher-risk colon cancer before surgery.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 400 (estimated) |
| Sponsor | City of Hope Medical Center Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Duarte, California) |
| Status | Recruiting |
| Started | January 15, 2025 |
| Main results expected | June 18, 2028 |
| Study ends | June 18, 2028 |
| Registry record updated | July 7, 2026 |
| Trial ID | NCT07255729 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
People with pathologically confirmed colon adenocarcinoma who have preoperative plasma or serum available and are undergoing curative-intent resection are the intended candidates.
✕Probably not a fit
Patients without preoperative blood samples, with non-adenocarcinoma histology, or lacking clinical/follow-up data would not benefit from this study's testing or model development.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
The EXPOSE initiative aims to develop a noninvasive biomarker panel using exosomal microRNAs measured from preoperative plasma to improve identification of patients equivalent to pathological stage IIB or higher. The study proceeds in phases: discovery using small RNA sequencing to find candidate microRNAs, a training phase quantifying candidates by RT-qPCR, and subsequent machine-learning model development for risk stratification. The goal is to combine molecular signals with clinical information to better direct neoadjuvant chemotherapy decisions. Samples and clinical data will be collected and analyzed to build and validate the diagnostic assay.
Why it matters
Potential benefit: If successful, this test could help identify patients who should get neoadjuvant chemotherapy before surgery, potentially reducing recurrence risk.
How similar studies have gone: Early research into circulating and exosomal microRNAs for cancer staging and prognosis has shown promise but remains preliminary and not yet widely established for clinical decision-making.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
City of Hope Medical Center
Duarte, California, United States Recruiting
Study contacts
- Principal investigator: Ajay Goel, PhD — City of Hope Medical Center
- Study coordinator: Ajay Goel, PhD
- Email: ajgoel@coh.org
- Phone: 626-218-3452
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.