LyMIC
An Exosome-based Liquid Biopsy Signature for Pre-operative Identification of Lymph Node Metastasis in Patients With Intrahepatic Cholangiocarcinoma
Sponsor study identifier
observational
230
2 countries
4
Study Start
April 15, 2023
Actual (reported)Primary Completion
June 1, 2025
Actual (reported)Study Completion
July 1, 2025
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
July 1, 2025
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
April 15, 2023
Actual (reported)April 19, 2024
Actual (reported)April 24, 2024
Actual (reported)June 1, 2025
Actual (reported)July 1, 2025
Actual (reported)Sensitivity
True Positive Rate: the probability of a positive test result, conditioned on the individual truly being positive
Through study completion, an average of 1 year
Specificity
Through study completion, an average of 1 year
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
Patients with ICC who had lymph node metastases at the time of primary tumor treatment with D2 dissection, in the first cohort.
Patients with ICC who did not have lymph node metastases at the time of primary tumor treatment with D2 dissection, in the first cohort.
Patients with ICC who had lymph node metastases at the time of primary tumor treatment with D2 dissection, in the second cohort.
Patients with ICC who did not have lymph node metastases at the time of primary tumor treatment with D2 dissection, in the second cohort.
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)
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Individuals who were diagnosed with Intrahepatic cholangiocarcinoma
City of Hope Medical Center
Duarte, California, 91016, United States
Department of Gastroenterological Surgery I, Graduate School of Medicine, Hokkaido University
Hokkaido, Sapporo, 060-8648, Japan
Department of Surgery and Science, Graduate School of Medical Sciences, Kyushu University
Fukuoka, 812-8582, Japan
Department of Surgery, Tokushima University
Tokushima, 770-8503, Japan
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Ajay Goel, PhD
City of Hope Medical Center
230 participants (actual enrollment reported by the registry).
First Submitted
April 19, 2024
First Posted
April 24, 2024
Study Start
April 15, 2023
Actual (reported)A Single-Arm Study of Pembrolizumab With Gemcitabine and Cisplatin as Perioperative Therapy for Potentially Resectable Intrahepatic Cholangiocarcinoma
Contact the study team to confirm eligibility.
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Morine Y, Shimada M. The value of systematic lymph node dissection for intrahepatic cholangiocarcinoma from the viewpoint of liver lymphatics. J Gastroenterol. 2015 Sep;50(9):913-27. doi: 10.1007/s00535-015-1071-2. Epub 2015 Apr 2.
Endo I, Gonen M, Yopp AC, Dalal KM, Zhou Q, Klimstra D, D'Angelica M, DeMatteo RP, Fong Y, Schwartz L, Kemeny N, O'Reilly E, Abou-Alfa GK, Shimada H, Blumgart LH, Jarnagin WR. Intrahepatic cholangiocarcinoma: rising frequency, improved survival, and determinants of outcome after resection. Ann Surg. 2008 Jul;248(1):84-96. doi: 10.1097/SLA.0b013e318176c4d3.
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Nishioka E, Tsurusaki M, Kozuki R, Im SW, Kono A, Kitajima K, Murakami T, Ishii K. Comparison of Conventional Imaging and 18F-Fluorodeoxyglucose Positron Emission Tomography/Computed Tomography in the Diagnostic Accuracy of Staging in Patients with Intrahepatic Cholangiocarcinoma. Diagnostics (Basel). 2022 Nov 21;12(11):2889. doi: 10.3390/diagnostics12112889.
Primary Completion
June 1, 2025
Actual (reported)Study Completion
July 1, 2025
Actual (reported)Last Updated
March 13, 2026
Record last verified: 2026-03
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Source: ClinicalTrials.gov.
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