Detecting Lymph Node Metastasis in Intrahepatic Cholangiocarcinoma (LyMIC)
- Conditions
- Cholangiocarcinoma, IntrahepaticCholangiocarcinoma ResectableCholangiocarcinomaCholangiocarcinoma; Liver
- Interventions
- Diagnostic Test: LyMIC (Lymph Node Metastasis in Intrahepatic Cholangiocarcinoma)
- Registration Number
- NCT06381648
- Lead Sponsor
- City of Hope Medical Center
- Brief 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 200
- A histologically confirmed diagnosis of intrahepatic cholangiocarcinoma.
- Received standard diagnostic and staging procedures as per local guidelines
- Availability of at least one blood-derived sample, drawn before receiving any curative-intent treatment
- Lack of or inability to provide informed consent
- Synchronous Intrahepatic cholangiocarcinoma and non- Intrahepatic cholangiocarcinoma diagnosed at or before surgery
- Secondary liver cancer
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Intrahepatic Cholangiocarcinoma, Without Lymph node metastasis (Validation) LyMIC (Lymph Node Metastasis in Intrahepatic Cholangiocarcinoma) Patients with ICC who did not have lymph node metastases at the time of primary tumor treatment with D2 dissection, in the second cohort. Intrahepatic Cholangiocarcinoma, With Lymph node metastasis (Training) LyMIC (Lymph Node Metastasis in Intrahepatic Cholangiocarcinoma) Patients with ICC who had lymph node metastases at the time of primary tumor treatment with D2 dissection, in the first cohort. Intrahepatic Cholangiocarcinoma, Without Lymph node metastasis (Training) LyMIC (Lymph Node Metastasis in Intrahepatic Cholangiocarcinoma) Patients with ICC who did not have lymph node metastases at the time of primary tumor treatment with D2 dissection, in the first cohort. Intrahepatic Cholangiocarcinoma, With Lymph node metastasis (Validation) LyMIC (Lymph Node Metastasis in Intrahepatic Cholangiocarcinoma) Patients with ICC who had lymph node metastases at the time of primary tumor treatment with D2 dissection, in the second cohort.
- Primary Outcome Measures
Name Time Method Sensitivity Through study completion, an average of 1 year True Positive Rate: the probability of a positive test result, conditioned on the individual truly being positive
- Secondary Outcome Measures
Name Time Method Specificity Through study completion, an average of 1 year True Negative Rate: the probability of a negative test result, conditioned on the individual truly being negative
Proportion of correct predictions (true positives and true negatives) among the total number of cases (i.e., accuracy) Through study completion, an average of 1 year A measure of trueness: proportion of correct predictions (both true positives and true negatives) among the total number of cases examined
Trial Locations
- Locations (4)
City of Hope Medical Center
🇺🇸Duarte, California, United States
Department of Gastroenterological Surgery I, Graduate School of Medicine, Hokkaido University
🇯🇵Hokkaido, Sapporo, Japan
Department of Surgery, Tokushima University
🇯🇵Tokushima, Japan
Department of Surgery and Science, Graduate School of Medical Sciences, Kyushu University
🇯🇵Fukuoka, Japan