About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
Adults (≥18 years old)
Histologically- or cytologically-confirmed colorectal cancer that is metastatic
Availability of pre-treatment plasma samples
Written informed consent provided
Disqualifiers
Prior malignancies within 5 years
Poor sample quality or hemolysis
Inability to provide informed consent
Trial population
Patients diagnosed with colorectal liver metastases (CRLM) originating from histologically confirmed colorectal adenocarcinoma at participating institutions.
Trial design
Case-control
Retrospective
Treatments tested in this trial
EXELION
Other interventionA panel of exosomal microRNA, whose expression level is tested in serum or plasma
Treatment groups
6
Treatment groupsSee each treatment group below.
Trial outcomes
Primary outcomes
Sensitivity
True positive rate: the probability of a positive test result, conditioned on the individual truly being positive
Secondary outcomes
Specificity
True negative rate: the probability of a negative test result, conditioned on the individual truly being negative
Accuracy
A measure of trueness: proportion of correct predictions (both true positives and true negatives) among the total number of cases examined
Sponsors and contacts
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