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Liquid Biopsy Using Exosomal miRNA Enables Risk Stratification of Potential Metastasis in Patients With Intrahepatic Cholangiocarcinoma.

NCT07224737 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 230

Last updated 2026-03-13

No results posted yet for this study

Summary

Occult metastasis at the time of surgery is a major driver of poor outcomes in intrahepatic cholangiocarcinoma (ICC), yet reliable preoperative biomarkers to identify such patients are lacking. The EXOMIC study aims to develop and validate a circulating exosomal microRNA (exo-miRNA)-based liquid biopsy assay to detect occult metastasis preoperatively in patients with resectable ICC.

Conditions

  • Intrahepatic Cholangiocarcinoma (Icc)

Interventions

DIAGNOSTIC_TEST

EXOMIC small RNA sequencing

High-throughput small RNA sequencing performed on preoperative serum or plasma samples from patients with intrahepatic cholangiocarcinoma (ICC) to identify exosome-derived microRNAs associated with occult metastasis at the time of surgery. Sequencing data were analyzed to detect differentially expressed miRNAs between patients with and without occult metastasis in the discovery cohort.

DIAGNOSTIC_TEST

EXOMIC assay (qRT-PCR validation)

Quantitative reverse transcription PCR (qRT-PCR)-based validation of candidate exosomal microRNAs identified through small RNA sequencing. This assay was performed on preoperative serum or plasma samples from independent ICC patient cohorts to validate the predictive value of selected miRNAs for occult metastasis detection prior to surgical resection.

Sponsors & Collaborators

  • City of Hope Medical Center

    lead OTHER

Principal Investigators

  • Ajay Goel, PhD · City of Hope Medical Center

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-06-21
Primary Completion
2026-01-18
Completion
2026-02-18

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07224737 on ClinicalTrials.gov