An Exosomal miRNA-based Liquid Biopsy for ICC Detection (LUMIC)

March 11, 2026 updated by: City of Hope Medical Center

Liquid Biopsy Using Exosomal miRNA for Intrahepatic Cholangiocarcinoma Detection

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

535

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Duarte, California, United States, 91016
        • City of Hope Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Individuals diagnosed with intrahepatic cholangiocarcinoma and control participants (non-cancer or benign biliary disease) with available pre-treatment plasma samples.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Intrahepatic Cholangiocarcinoma (Discovery, Small RNA-seq)
Serum and plasma samples from patients with histologically confirmed ICC will be analyzed using small RNA sequencing to identify circulating miRNAs specifically upregulated in ICC. These miRNAs will serve as candidates for downstream validation.
Diagnostic test: Small RNA sequencing
Small RNA sequencing of serum/plasma RNA to identify ICC-specific upregulated miRNAs
Non-disease Control (Discovery, Small RNA-seq)
Serum and plasma samples from individuals without malignant or inflammatory liver diseases (benign or healthy controls) will be analyzed in parallel by small RNA sequencing to identify miRNAs differentially expressed between ICC and non-disease controls.
Diagnostic test: Small RNA sequencing
Small RNA sequencing of serum/plasma RNA to identify ICC-specific upregulated miRNAs
Non-disease Control (Training)
Individuals without malignant or inflammatory liver diseases (benign or healthy controls) whose serum/plasma samples will serve as controls to establish baseline miRNA expression and diagnostic thresholds.
Diagnostic test: LUMIC assay
RT-qPCR validation of selected miRNAs
Intrahepatic Cholangiocarcinoma (Validation)
Independent ICC cohort used for external validation of the LUMIC assay to confirm diagnostic performance and reproducibility.
Diagnostic test: LUMIC assay
RT-qPCR validation of selected miRNAs
Non-disease Control (Validation)
Individuals without malignant or inflammatory liver diseases (benign or healthy controls) whose serum/plasma samples will be used for validation of specificity and model robustness.
Diagnostic test: LUMIC assay
RT-qPCR validation of selected miRNAs
Intrahepatic Cholangiocarcinoma (Training)
Patients with histologically confirmed ICC whose pre-treatment serum or plasma samples will be used to construct and optimize the exo-miRNA diagnostic panel based on discovery-phase candidates.
Diagnostic test: LUMIC assay
RT-qPCR validation of selected miRNAs

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sensitivity
Time Frame: Through study completion (~1 year)
The proportion of true positive ICC cases correctly identified by the LUMIC assay.
Through study completion (~1 year)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Specificity
Time Frame: Through study completion (~1 year)
The proportion of true negative cases correctly classified as non-ICC.
Through study completion (~1 year)
Diagnostic accuracy (AUC)
Time Frame: Through study completion (~1 year)
The overall discriminative ability of the exo-miRNA panel for ICC detection.
Through study completion (~1 year)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

City of Hope Medical Center

Investigators

  • Principal Investigator: Ajay Goel, PhD, City of Hope Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 21, 2024

Primary Completion (Actual)

January 5, 2026

Study Completion (Actual)

February 5, 2026

Study Registration Dates

First Submitted

November 4, 2025

First Submitted That Met QC Criteria

November 4, 2025

First Posted (Actual)

November 6, 2025

Study Record Updates

Last Update Posted (Actual)

March 13, 2026

Last Update Submitted That Met QC Criteria

March 11, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 23228/LUMIC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Data collected for the study will be made available to others, including de-identified participant data, at publication, via a signed data access agreement and at the discretion of the investigators' approval of the proposed use of such data

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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