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A Cell-free and Exosomal miRNA-based Liquid Biopsy for ICC Detection

A Cell-free and Exosomal miRNA-based Liquid Biopsy for ICC Detection

Recruiting
18 years and older
All
Phase N/A

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Overview

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 cell-free and exosomal microRNAs (cf- and exo-miRNAs) to detect intrahepatic cholangiocarcinoma with high sensitivity and specificity.

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 circulating cell-free and exosomal microRNAs (cf- and exo-miRNAs) can serve as promising, minimally invasive biomarkers reflecting tumor biology and microenvironmental changes.

The LUMIC study (Liquid biopsy Using cell-free and 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 cf-/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.

Eligibility

Inclusion Criteria:

  • Age ≥ 18 years
  • Histologically confirmed intrahepatic cholangiocarcinoma
  • Availability of pre-treatment plasma sample
  • Informed consent provided

Exclusion Criteria:

  • Extrahepatic cholangiocarcinoma
  • History of other malignancy within 5 years
  • Active infection, autoimmune disease, or pregnancy
  • Inadequate clinical data or poor sample quality

Study details
    Intrahepatic Cholangiocarcinoma (Icc)

NCT07225452

City of Hope Medical Center

1 February 2026

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