Blood test using exosome microRNAs to find extrahepatic spread in colorectal cancer with liver metastases
Exosome-derived Extrahepatic Metastasis Detection By Liquid Biopsy In Colorectal Cancer Liver Metastases
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 |
|---|---|
| Enrollment | 500 (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 | NCT07224724 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 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.