RecruitingNCT07224724

Exosome-derived Extrahepatic Metastasis Detection By Liquid Biopsy In Colorectal Cancer Liver Metastases


Sponsor

City of Hope Medical Center

Enrollment

500 participants

Start Date

Jun 1, 2024

Study Type

OBSERVATIONAL

Conditions

Summary

Colorectal cancer is the third most common malignancy worldwide, and prognosis largely depends on how effectively metastatic disease is managed. The liver is the most frequent and prognostically important site of metastasis, and patients responding well to chemotherapy may become candidates for curative hepatic resection. However, the presence of extrahepatic metastasis (EHM) critically influences treatment eligibility and survival. Although clinical scores such as the Fong and Beppu systems include EHM as a determinant, its detection by imaging remains limited, especially for small or occult lesions. Accurate identification of EHM is also essential when considering liver transplantation for unresectable colorectal liver metastases (CRLM), where EHM remains an exclusion criterion. The EXELION Study aims to develop a non-invasive diagnostic model using serum exosomal microRNAs (miRNAs) to detect both hepatic and extrahepatic metastases in patients with CRLM. By integrating circulating miRNA profiling with machine learning-based analysis, this study seeks to supplement imaging diagnostics, improve treatment stratification, and enhance clinical decision-making for metastatic colorectal cancer.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is examining blood samples (liquid biopsies) from people with colorectal cancer that has spread to the liver, to see whether tiny particles released by the tumor — called exosomes — can reveal whether the cancer has also spread to other parts of the body beyond the liver. This could help doctors make better treatment decisions without needing additional scans or biopsies. **You may be eligible if...** - You are 18 years or older - You have been diagnosed with colorectal cancer that has spread (metastatic), confirmed by biopsy or lab test - You have pre-treatment blood (plasma) samples available for analysis - Sufficient clinical and imaging records are available to determine whether your cancer has spread beyond the liver - You are willing to provide written informed consent **You may NOT be eligible if...** - You have had another cancer in the past 5 years - Your blood samples are of poor quality or show signs of hemolysis (red blood cell breakdown) - You are unable to provide informed consent Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHEREXELION

A panel of exosomal microRNA, whose expression level is tested in serum or plasma


Locations(1)

City of Hope Medical Center

Duarte, California, United States

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NCT07224724


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