Liquid Biopsy Using Exosomal miRNA for Intrahepatic Cholangiocarcinoma Detection
Status: Recruiting
Location: See location...
Intervention Type: Diagnostic test
Study Type: Observational
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: t
View:
• Age ≥ 18 years
• Histologically confirmed intrahepatic cholangiocarcinoma
• Availability of pre-treatment plasma sample
• Informed consent provided
Locations
United States
California
City of Hope Medical Center
RECRUITING
Duarte
Contact Information
Primary
Ajay Goel, PhD
ajgoel@coh.org
626-218-3452
Time Frame
Start Date: 2024-06-21
Estimated Completion Date: 2026-06-18
Participants
Target number of participants: 500
Treatments
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.
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.
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.
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.
Intrahepatic Cholangiocarcinoma (Validation)
Independent ICC cohort used for external validation of the LUMIC assay to confirm diagnostic performance and reproducibility.
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.
Related Therapeutic Areas
Sponsors
Leads: City of Hope Medical Center