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

Inclusion Criteria5

  • 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 Criteria3

  • Prior malignancies within 5 years
  • Poor sample quality or hemolysis
  • Inability to provide informed consent

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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