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NCT07224737 | RECRUITING | Intrahepatic Cholangiocarcinoma (Icc)

Liquid Biopsy Using Exosomal miRNA Enables Risk Stratification of Potential Metastasis in Patients With Intrahepatic Cholangiocarcinoma.
Sponsor:

City of Hope Medical Center

Brief Summary:

Occult metastasis at the time of surgery is a major driver of poor outcomes in intrahepatic cholangiocarcinoma (ICC), yet reliable preoperative biomarkers to identify such patients are lacking. The EXOMIC study aims to develop and validate a circulating exosomal microRNA (exo-miRNA)-based liquid biopsy assay to detect occult metastasis preoperatively in patients with resectable ICC.

Condition or disease

Intrahepatic Cholangiocarcinoma (Icc)

Intervention/treatment

EXOMIC small RNA sequencing

EXOMIC assay (qRT-PCR validation)

Detailed Description:

Intrahepatic cholangiocarcinoma (ICC) incidence is rising globally, and prognosis remains poor. Patients harboring occult micrometastases that are not detected on preoperative imaging often experience rapid recurrence and significantly worse survival. Tumor-derived exosomes contribute to pre-metastatic niche formation and carry microRNAs that reflect aggressive metastatic potential. Circulating exosomal microRNA profiles may serve as non-invasive biomarkers to reveal occult metastasis before surgery. Preoperative exosomes will be analyzed using small RNA sequencing (discovery) followed by RT-qPCR validation and machine-learning modeling to develop a predictive score for occult metastasis. The study will evaluate diagnostic performance (sensitivity, specificity, accuracy, AUROC), prognostic relevance (OS/RFS), and clinical utility (decision curve analysis) to establish a biologically informed framework for treatment stratification in ICC.

Study Type : OBSERVATIONAL
Estimated Enrollment : 250 participants
Official Title : Machine Learning-based Exosome Liquid Biopsy Enables Stratification of Occult Metastasis Risk in Patients With Intrahepatic Cholangiocarcinoma
Actual Study Start Date : 2024-06-21
Estimated Primary Completion Date : 2026-06-18
Estimated Study Completion Date : 2026-06-18

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
Inclusion Criteria
  • * Histologically confirmed ICC (clinical stage I-III).
  • * Undergoing curative-intent hepatectomy.
  • * Availability of preoperative pasma or serum sample (≥200 µL).
  • * Standard staging imaging completed per institutional protocol.
  • * Written informed consent.
Exclusion Criteria
  • * Extrahepatic cholangiocarcinoma or gallbladder cancer.
  • * Synchronous non-ICC malignancy.
  • * Inadequate clinical follow-up.
  • * Inability to consent.
Liquid Biopsy Using Exosomal miRNA Enables Risk Stratification of Potential Metastasis in Patients With Intrahepatic Cholangiocarcinoma.

Location Details

NCT07224737

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Locations

RECRUITING

United States, California

City of Hope Medical Center

Duarte, California, United States, 91016