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

RecruitingObservational study

Who can join

Ages 18 and older · All sexes

Full eligibility 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

About the study

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.

What is being tested

Sponsor: City of Hope Medical Center · Participants: 500 · Started: Jun 1, 2024

Contact the study team

Official record on ClinicalTrials.gov — NCT07224724

Locations in the U.S.

CaliforniaCity of Hope Medical Center, Duarte

Conditions

From ClinicalTrials.gov, data retrieved Oct 2, 2026. Each study sets its own eligibility; the study team decides who can join.