protocolSection identificationModule nctId: NCT06381648, orgStudyIdInfo id: 23228/LyMIC, briefTitle: Detecting Lymph Node Metastasis in Intrahepatic Cholangiocarcinoma (LyMIC), acronym: LyMIC, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-04-15, primaryCompletionDateStruct date: 2026-06-18, completionDateStruct date: 2026-06-18, studyFirstPostDateStruct date: 2024-04-24, lastUpdatePostDateStruct date: 2024-04-25, sponsorCollaboratorsModule leadSponsor name: City of Hope Medical Center, class: OTHER, descriptionModule briefSummary: 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., conditionsModule conditions: Cholangiocarcinoma, conditions: Cholangiocarcinoma, Intrahepatic, conditions: Cholangiocarcinoma Resectable, conditions: Cholangiocarcinoma; Liver, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: RETROSPECTIVE, enrollmentInfo count: 200, type: ESTIMATED, armsInterventionsModule interventions name: LyMIC (Lymph Node Metastasis in Intrahepatic Cholangiocarcinoma), outcomesModule primaryOutcomes measure: Sensitivity, secondaryOutcomes measure: Specificity, secondaryOutcomes measure: Proportion of correct predictions (true positives and true negatives) among the total number of cases (i.e., accuracy), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: City of Hope Medical Center, status: RECRUITING, city: Duarte, state: California, zip: 91016, country: United States, contacts name: Ajay Goel, PhD, role: CONTACT, phone: 626-218-3452, email: AJGOEL@COH.ORG, contacts name: Ajay Goel, PhD, role: PRINCIPAL_INVESTIGATOR, contacts name: Takayuki Noma, MD, role: SUB_INVESTIGATOR, geoPoint lat: 34.13945, lon: -117.97729, locations facility: Department of Gastroenterological Surgery I, Graduate School of Medicine, Hokkaido University, status: RECRUITING, city: Hokkaido, state: Sapporo, zip: 060-8648, country: Japan, contacts name: Akinobu Taketomi, PhD, role: CONTACT, email: akinobutaketomi@yahoo.co.jp, contacts name: Kazuki Wakizaka, PhD, role: SUB_INVESTIGATOR, contacts name: Akinobu Taketomi, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 43.41104, lon: 142.88878, locations facility: Department of Surgery and Science, Graduate School of Medical Sciences, Kyushu University, status: RECRUITING, city: Fukuoka, zip: 812-8582, country: Japan, contacts name: Masaki Mori, PhD, role: CONTACT, email: m_mori@surg2.med.kyushu-u.ac.jp, contacts name: Masaki Mori, PhD, role: PRINCIPAL_INVESTIGATOR, contacts name: Takeo Toshima, PhD, role: SUB_INVESTIGATOR, geoPoint lat: 33.6, lon: 130.41667, locations facility: Department of Surgery, Tokushima University, status: RECRUITING, city: Tokushima, zip: 770-8503, country: Japan, contacts name: Mitsuo Shimada, PhD, role: CONTACT, email: mitsuo.shimada@tokushima-u.ac.jp, contacts name: Yuma Wada, PhD, role: SUB_INVESTIGATOR, contacts name: Takayuki Noma, MD, role: SUB_INVESTIGATOR, contacts name: Yuji Morine, PhD, role: SUB_INVESTIGATOR, contacts name: Tetsuya Ikemoto, PhD, role: SUB_INVESTIGATOR, contacts name: Yu Saito, PhD, role: SUB_INVESTIGATOR, contacts name: Mitsuo Shimada, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 34.06667, lon: 134.56667, hasResults: False