Blood test of exosomal microRNAs to stage colon cancer before surgery
Machine Learning-Based Exosomal microRNA Signature for Preoperative Staging and Chemotherapy Eligibility in Colon Cancer
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 |
|---|---|
| Enrollment | 400 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | City of Hope Medical Center Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Duarte, California) |
| Trial ID | NCT07255729 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Duarte, California
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.