protocolSection identificationModule nctId: NCT06342414, orgStudyIdInfo id: 23228/ELUCIDATE, briefTitle: An Exosome-Based Liquid Biopsy for the Differential Diagnosis of Primary Liver Cancer, acronym: ELUCIDATE, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-15, primaryCompletionDateStruct date: 2025-03-15, completionDateStruct date: 2025-03-15, studyFirstPostDateStruct date: 2024-04-02, lastUpdatePostDateStruct date: 2024-04-02, sponsorCollaboratorsModule leadSponsor name: City of Hope Medical Center, class: OTHER, descriptionModule briefSummary: It is sometimes difficult to precisely understand whether a primary liver cancer is a hepatocellular carcinoma or a cholangiocarcinoma. The researchers will develop and validate a liquid biopsy, based on exosomal content analysis and powered by machine learning, to help clinicians differentiate these two cancers before surgery., conditionsModule conditions: Hepatocellular Carcinoma, conditions: Intrahepatic Cholangiocarcinoma, conditions: Cholangiocarcinoma, conditions: Primary Liver Cancer, conditions: Primary Liver Carcinoma, conditions: Hepatic Cancer, conditions: Hepatic Carcinoma, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: RETROSPECTIVE, enrollmentInfo count: 400, type: ESTIMATED, armsInterventionsModule interventions name: ELUCIDATE, 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: 91010, country: United States, contacts name: Ajay Goel, PhD, role: CONTACT, phone: 626-218-3452, email: AJGOEL@COH.ORG, contacts name: Caiming Xu, MD, PhD, role: SUB_INVESTIGATOR, contacts name: Yoh Asahi, MD, role: PRINCIPAL_INVESTIGATOR, contacts name: Ajay Goel, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 34.13945, lon: -117.97729, locations facility: Graduate School of Medical Sciences, Kyushu University, status: RECRUITING, city: Fukuoka, country: Japan, contacts name: Tomoharu Yoshizumi, role: CONTACT, contacts name: Tomoharu Yoshizumi, role: SUB_INVESTIGATOR, contacts name: Takeo Toshima, role: SUB_INVESTIGATOR, geoPoint lat: 33.6, lon: 130.41667, locations facility: Graduate School of Medical Sciences, Kumamoto University, status: RECRUITING, city: Kumamoto, country: Japan, contacts name: Hideo Baba, role: CONTACT, contacts name: Hideo Baba, role: SUB_INVESTIGATOR, geoPoint lat: 32.80589, lon: 130.69182, locations facility: Hokkaido University Graduate School of Medicine, status: RECRUITING, city: Sapporo, country: Japan, contacts name: Akinobu Taketomi, role: CONTACT, contacts name: Akinobu Taketomi, role: PRINCIPAL_INVESTIGATOR, contacts name: Yoh Asahi, role: PRINCIPAL_INVESTIGATOR, contacts name: Tatsuhiko Kakisaka, role: SUB_INVESTIGATOR, geoPoint lat: 43.06667, lon: 141.35, locations facility: Tokushima University, status: RECRUITING, city: Tokushima, country: Japan, contacts name: Mitsuo Shimada, role: CONTACT, contacts name: Mitsuo Shimada, role: SUB_INVESTIGATOR, contacts name: Katsuki Miyazaki, role: SUB_INVESTIGATOR, geoPoint lat: 34.06667, lon: 134.56667, hasResults: False