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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorCity of Hope Medical Center

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 volunteers

Qualifiers

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

Design model

Case-control

Time perspective

Retrospective

Treatments tested in this trial

  • EXELION

    Other intervention

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

Treatment groups

500 Participants
are divided into 6 treatment groups

6

Treatment groups

See each treatment group below.

Group A: Extrahepatic liver metastasis patients(Discovery Cohort)0 interventions
Group B: Non-extrahepatic liver metastasis patients(Discovery Cohort)1 intervention
Group C: Extrahepatic liver metastasis patients(Training Cohort)1 intervention
Group D: Non-extrahepatic liver metastasis patients (Training Cohort)1 intervention
Group E: Extrahepatic liver metastasis patients (Validation Cohort)0 interventions
Group F: Non-extrahepatic liver metastasis patients (Validation Cohort)1 intervention

Trial outcomes

Primary outcomes

1

Sensitivity

True positive rate: the probability of a positive test result, conditioned on the individual truly being positive

Time frame
Through study completion, an average of 1 year

Secondary outcomes

1

Specificity

True negative rate: the probability of a negative test result, conditioned on the individual truly being negative

Time frame
Through study completion, an average of 1 year
2

Accuracy

A measure of trueness: proportion of correct predictions (both true positives and true negatives) among the total number of cases examined

Time frame
Through study completion, an average of 1 year

Other outcomes

Sponsors and contacts

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