Clinical trial NCT06381648: Detecting Lymph Node Metastasis in Intrahepatic Cholangiocarcinoma (LyMIC)
Official title: An Exosome-based Liquid Biopsy Signature for Pre-operative Identification of Lymph Node Metastasis in Patients With Intrahepatic Cholangiocarcinoma
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cholangiocarcinoma
Cholangiocarcinoma, Intrahepatic
Cholangiocarcinoma Resectable
Cholangiocarcinoma; Liver
Keywords: Intrahepatic cholangiocarcinoma
Exosome
micro-RNA
Liquid biopsy
Blood test
Lymph node metastasis
Lymph node dissection
Lymphadenectomy
Lead sponsor: City of Hope Medical Center
Sponsor class: OTHER
First posted: 2024-04-24
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Individuals who were diagnosed with Intrahepatic cholangiocarcinoma

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* Lack of or inability to provide informed consent
* Synchronous Intrahepatic cholangiocarcinoma and non- Intrahepatic cholangiocarcinoma diagnosed at or before surgery
* Secondary liver cancer

Primary outcomes:
measure: Sensitivity
timeFrame: Through study completion, an average of 1 year
Secondary outcomes:
measure: Specificity
timeFrame: Through study completion, an average of 1 year
measure: Proportion of correct predictions (true positives and true negatives) among the total number of cases (i.e., accuracy)
timeFrame: Through study completion, an average of 1 year
Other outcomes:
Locations:
city: Duarte
country: United States
facility: City of Hope Medical Center
state: California
city: Hokkaido
country: Japan
facility: Department of Gastroenterological Surgery I, Graduate School of Medicine, Hokkaido University
state: Sapporo
city: Fukuoka
country: Japan
facility: Department of Surgery and Science, Graduate School of Medical Sciences, Kyushu University
city: Tokushima
country: Japan
facility: Department of Surgery, Tokushima University
Study officials:
affiliation: City of Hope Medical Center
name: Ajay Goel, PhD
role: PRINCIPAL_INVESTIGATOR
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