NCT06381648

Detecting Lymph Node Metastasis in Intrahepatic Cholangiocarcinoma (LyMIC)

An Exosome-based Liquid Biopsy Signature for Pre-operative Identification of Lymph Node Metastasis in Patients With Intrahepatic Cholangiocarcinoma

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 230 (actual)
• Sponsor: City of Hope Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Lymph node metastasis (LNM) is a major prognostic factor in intrahepatic cholangiocarcinoma (ICC), and accurate preoperative prediction of the presence or absence of LNM has significant clinical implications in determining treatment strategy. Despite this, there are currently no reliable biomarkers established to detect LNM in ICC. This study seeks to develop a liquid biopsy assay that can accurately detect LNM before treatment in ICC patients.

Detailed description

Intrahepatic cholangiocarcinoma (ICC) is a malignant tumor of the liver arising from epithelial cells of the biliary tract, accounting for 10-15% of primary liver cancers, and the incidence of ICC has increased rapidly worldwide over the past decade. The long-term prognosis is dismal, with a 5-year overall survival (OS) as low as 25-30%. Many studies have highlighted lymph node metastasis as a strong predictor of poor prognosis in ICC patients, prompting efforts such as appropriate lymphadenectomy to accurately predict disease stage and reduce outcomes associated with LNM. Adequate lymphadenectomy in patients with suspected LNM is essential for achieving R0 resection and is a necessary component of complete cure and long-term survival. The routine use of highly invasive lymphadenectomy in all patients remains controversial, and lymphadenectomy rates for ICC range from 26.9% to 100% depending on the literature and are not universally adopted currently. Currently, LNM is detected preoperatively by imaging, but imaging alone is not sufficient to diagnose LNM, as negative findings by imaging findings may have low sensitivity and may not rule out LNM. Other attempts have been made to develop predictive scoring systems based on Carbohydrate antigen 19-9 (CA 19-9) levels, location of the primary tumor, lymph node patterns on CT and MRI, and other clinical factors to predict LNM in ICC, but all these predictive systems rely heavily on judgment regarding lymph node size and tumor growth patterns are largely left to diagnostic imaging. This study seeks to validate a panel of more accurate and non-invasive biomarkers (exo-miRNAs) in preoperative blood samples. Accurate preoperative detection of the presence of LNM would help provide clear criteria for ICC treatment decisions, such as the implementation of elective lymphadenectomy or the addition of chemotherapy.

Conditions

• Cholangiocarcinoma
• Cholangiocarcinoma, Intrahepatic
• Cholangiocarcinoma Resectable
• Cholangiocarcinoma; Liver

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	LyMIC (Lymph Node Metastasis in Intrahepatic Cholangiocarcinoma)	A panel of exosomal miRNAs, whose expression levels are tested in serum or plasma samples collected prior to primary tumor resection, with reverse transcriptase-quantitative polymerase chain reaction (RT-qPCR)

Timeline

• Start date: 2023-04-15
• Primary completion: 2025-06-01
• Completion: 2025-07-01
• First posted: 2024-04-24
• Last updated: 2026-03-13

Locations

4 sites across 2 countries: United States, Japan