Blood test using exosome microRNAs to find extrahepatic spread in colorectal cancer with liver metastases
Official title: Exosome-derived Extrahepatic Metastasis Detection By Liquid Biopsy In Colorectal Cancer Liver Metastases
Run by City of Hope Medical Center · NCT07224724 · Data updated 2026-11-12
This project will test whether a blood test measuring exosome microRNAs can detect extrahepatic metastases in adults whose colorectal cancer has spread to the liver.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 500 (estimated) |
| Sponsor | City of Hope Medical Center Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Duarte, California) |
| Status | Recruiting |
| Started | June 1, 2024 |
| Main results expected | June 18, 2028 |
| Study ends | June 18, 2028 |
| Registry record updated | July 7, 2026 |
| Trial ID | NCT07224724 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (≥18) with histologically- or cytologically-confirmed metastatic colorectal cancer involving the liver who can provide pre-treatment plasma samples and have sufficient clinical and imaging records are ideal candidates.
✕Probably not a fit
Patients without liver metastases, those with another malignancy within the past five years, those with poor-quality or hemolyzed samples, or those unable to provide informed consent are unlikely to benefit from this protocol.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
Accurate detection of extrahepatic metastasis (EHM) is critical for selecting patients with colorectal liver metastases (CRLM) for curative liver surgery or transplant, but imaging can miss small or occult lesions. The study will use serum exosomal microRNA profiling with next-generation sequencing in a discovery phase to identify candidate markers associated with EHM. Investigators will then build a quantitative RT-qPCR assay and train a predictive algorithm using machine learning, followed by independent validation of the model in a separate cohort. This is an observational effort enrolling adults with CRLM who can provide pre-treatment plasma and linked clinical/imaging data.
Why it matters
Potential benefit: If successful, the test could identify hidden metastases earlier and help doctors choose the right patients for curative liver surgery or transplant.
How similar studies have gone: Prior work has linked circulating and exosomal miRNA patterns to liver metastasis, treatment response, and recurrence in colorectal cancer, but using them specifically to detect extrahepatic metastasis has not yet been validated in clinical cohorts.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adults (≥18 years old) * Histologically- or cytologically-confirmed colorectal cancer that is metastatic * Availability of pre-treatment plasma samples * Written informed consent provided * Sufficient clinical and imaging data to determine presence/absence of extrahepatic metastasis Exclusion Criteria: * Prior malignancies within 5 years * Poor sample quality or hemolysis * Inability to provide informed consent
Where it's running
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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.