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An Exosomal miRNA-based Liquid Biopsy for ICC Detection

Liquid Biopsy Using Exosomal miRNA for Intrahepatic Cholangiocarcinoma Detection

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07225452
Acronym
LUMIC
Enrollment
535
Registered
2025-11-06
Start date
2024-06-21
Completion date
2026-02-05
Last updated
2026-03-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intrahepatic Cholangiocarcinoma (Icc)

Keywords

ICC, Exosome, microRNA, miRNA, liquid biopsy, liver cancer

Brief 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.

Interventions

DIAGNOSTIC_TESTSmall RNA sequencing

Small RNA sequencing of serum/plasma RNA to identify ICC-specific upregulated miRNAs

DIAGNOSTIC_TESTLUMIC assay

RT-qPCR validation of selected miRNAs

Sponsors

City of Hope Medical Center
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
SensitivityThrough study completion (~1 year)The proportion of true positive ICC cases correctly identified by the LUMIC assay.

Secondary

MeasureTime frameDescription
SpecificityThrough study completion (~1 year)The proportion of true negative cases correctly classified as non-ICC.
Diagnostic accuracy (AUC)Through study completion (~1 year)The overall discriminative ability of the exo-miRNA panel for ICC detection.

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORAjay Goel, PhD

City of Hope Medical Center

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 14, 2026