NCT07225452

An Exosomal miRNA-based Liquid Biopsy for ICC Detection

Liquid Biopsy Using Exosomal miRNA for Intrahepatic Cholangiocarcinoma Detection

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 535 (actual)
• Sponsor: City of Hope Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

Intrahepatic cholangiocarcinoma (ICC) is a malignant liver tumor with poor prognosis and limited curative treatment options. Early and accurate detection remains an unmet clinical need. The LUMIC study aims to develop a non-invasive liquid biopsy platform based on both exosomal microRNAs (exo-miRNAs) to detect intrahepatic cholangiocarcinoma with high sensitivity and specificity.

Detailed description

Intrahepatic cholangiocarcinoma (ICC) is the second most common primary liver malignancy after hepatocellular carcinoma, accounting for approximately 10-15% of all primary liver cancers. Despite improvements in surgical techniques and imaging modalities, ICC is often diagnosed at advanced stages, resulting in dismal outcomes with a 5-year overall survival rate of 25-30%. Traditional imaging approaches such as CT and MRI have limited sensitivity for detecting early or small ICC lesions. Blood-based biomarkers, including CA19-9, also lack adequate specificity. Recent advances in liquid biopsy have demonstrated that exosomal microRNAs (exo-miRNAs) can serve as promising, minimally invasive biomarkers reflecting tumor biology and microenvironmental changes. The LUMIC study (Liquid biopsy Using exosomal miRNA for Intrahepatic Cholangiocarcinoma detection) aims to identify and validate miRNA signatures capable of distinguishing ICC from benign biliary or non-cancerous liver conditions. Blood samples are collected before treatment, and exo-miRNA expression profiles are analyzed using RT-qPCR and bioinformatic pipelines. Diagnostic performance (AUC, sensitivity, specificity) will be evaluated through training and validation cohorts. This study provides a foundation for integrating liquid biopsy-based diagnostics into ICC clinical workflows to enable earlier detection and improved treatment stratification.

Conditions

• Intrahepatic Cholangiocarcinoma (Icc)

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Small RNA sequencing	Small RNA sequencing of serum/plasma RNA to identify ICC-specific upregulated miRNAs
DIAGNOSTIC_TEST	LUMIC assay	RT-qPCR validation of selected miRNAs

Timeline

• Start date: 2024-06-21
• Primary completion: 2026-01-05
• Completion: 2026-02-05
• First posted: 2025-11-06
• Last updated: 2026-03-13

Locations

1 site across 1 country: United States