[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"EXoPERT\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":76},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,51],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":22,"studyType":23,"phases":4,"briefSummary":24,"conditions":25,"keywords":31,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":39,"lastUpdatePostDateStruct":40,"startDateStruct":43,"completionDateStruct":45,"leadSponsor":47,"locationsCount":50},"100607264","exopert-emerald-clinical-study-100607264",false,"NCT07186296","EXoPERT EMERALD Clinical Study","EXoPERT EMERALD: Early Multi-cancer Study of EV's Ramen-AL Linked Diagnosis Clinical Study Protocol","Inclusion Criteria:\n\n* Subject aged 45 years or older with a biopsy-proven or clinically suspected primary lung, breast, colorectal, pancreatic, or ovarian cancer, based on objective findings such as radiological, serological, endoscopic, or cytological findings, whose blood was collected prior to any systemic or definitive therapy for the cancer.\n* Subjects who are willing and able to provide written informed consent.\n* Subjects who are willing and able to comply with the study requirements.\n\nExclusion Criteria:\n\n* Any history of cancer diagnosed and treated within 5 years prior to the date of consent.\n* Subjects with a history of previous cancer treatment via surgical resection, hormonal cancer treatment, chemotherapy, radiotherapy within the past 6 months for recent cancer diagnosis.\n* Subjects who have any history of an allogeneic bone marrow, stem cell transplant, or solid organ transplant.\n* Subjects who are pregnant or breastfeeding women.\n* Subjects who have consented and have undergone treatment in any other cancer related clinical trials withinthe past 6 months.\n* Subjects who are currently in active treatment for drug abuse.\n* Subjects who have received any treatment related to lung, breast, colorectal, pancreatic, or ovarian nodules, such as hormones prior to entering the study.\n* Unsuitable sample for testing due to contamination, hemolysis, etc.",true,"ALL","45 Years",{"count":20,"type":21},1400,"ESTIMATED","1 Day","OBSERVATIONAL","The purpose of this study is to establish a multi-center clinical repository of blood samples to support the development and evaluation of an artificial intelligence-based in vitro diagnostic software. The software analyzes surface-enhanced Raman spectroscopy (SERS) profiles of extracellular vesicles (EVs) extracted from human plasma for the early detection of multiple cancers, including lung, ovarian, breast, pancreatic, and colorectal cancers.",[26,27,28,29,30],"Breast Cancer","Colon Cancer","Pancreatic Cancer","Ovarian Cancer","Lung Cancer",[32,33,34,35,36,37],"Early-stage","In vitro Diagnostic Test","Artificial intelligence","extracellular vesicles","multi cancer diagnosis","cancer","RECRUITING","2026-06-28",{"date":41,"type":42},"2026-07-01","ACTUAL",{"date":44,"type":42},"2025-05-09",{"date":46,"type":21},"2026-08-31",{"name":48,"class":49},"EXoPERT","INDUSTRY",9,{"id":52,"slug":53,"hasResults":11,"nctId":54,"briefTitle":55,"officialTitle":56,"acronym":4,"eligibilityCriteria":57,"healthyVolunteers":11,"sex":58,"minAge":59,"maxAge":4,"enrollmentInfo":60,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":62,"conditions":63,"keywords":65,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":5},"100567754","a-prospective-study-to-develop-and-clinically-validate-an-in-vitro-diagnostic-medical-device-that-uses-blood-to-classify-patients-at-high-risk-for-breast-cancer-100567754","NCT06672302","A Prospective Study to Develop and Clinically Validate an in Vitro Diagnostic Medical Device That Uses Blood to Classify Patients at High Risk for Breast Cancer","A Multi-center, Single Arm, Prospective Exploratory in Vitro Diagnostic Devices Clinical Performance Study to Evaluate of in Vitro Diagnostic Devices for Auxiliary Diagnosis That Classifies High-risk and Low Risk Patients With Breast Cancer by Analyzing Surface-enhanced Raman Spectroscopy (SERS) Profiles of Extracellular Vesicles (EVs) Extracted From Human Plasma Using Artificial Intelligence","Inclusion Criteria(Breast malignant nodule group)\n\n1. Korean nationality\n2. Voluntary written consent to participate in this clinical performance trial study\n3. Confirmed breast cancer through imaging\u002Fpathologic diagnostic tests\n4. Those who have been diagnosed with breast cancer at a stage prior to treatment and surgery, and who agree to participate in this study and are able to provide blood samples.\n5. Those whose lesions have been confirmed by conventional examination (breast ultrasound or mammography) and who fall into BI-RADS categories 4,5,6 and have undergone biopsy or are scheduled to undergo biopsy within 2 weeks.\n6. Those who meet the following demographic conditions A. Adult female, 40 years of age or older\n7. Those who can provide the following clinical information A. Age and biological sex B. Whether or not they have dense breasts C. Occupational information D. Pathological tumor size, Clinical tumor size, Pathological TNM staging, Clinical TNM staging, tumor location, breast cancer histology findings (breast cancer subtype) E. Family history and past history of cancer F. Breast-related diseases G. Chronic disease history\n\nInclusion Criteria(Breast benign nodule group)\n\n1. Korean nationality\n2. Voluntary written consent to participate in this clinical performance trial study\n3. Diagnosed with breast nodules through imaging\u002Fpathologic diagnostic tests\n4. Those who have been diagnosed with breast nodules and have agreed to participate in this study and are able to provide blood samples at a stage prior to treatment and surgery.\n5. Those whose lesions have been confirmed by conventional examination (breast ultrasound or mammography) and fall into BI-RADS categories 4,5,6 and have undergone biopsy or are scheduled for biopsy within 2 weeks\n6. Those who meet the following demographic conditions A. Adult female, 40 years of age or older\n7. Those who can provide the following clinical information A. Age and biological sex B. Whether or not they have dense breasts C. Occupational information D. Diagnosis, nodule size, and number of nodules E. Family history and past history of cancer F. Breast-related diseases G. Chronic disease history\n\nExclusion Criteria:\n\n1. Those who have been diagnosed with cancer (malignant tumor) of any type within 5 years of the date of consent and have undergone appropriate chemotherapy\u002Fradiation treatment or surgery.\n2. Those who are confirmed to have developed breast cancer due to metastasis from malignant tumors other than breast cancer\n3. Pregnant women\n4. Participation in a drug-related clinical trial within 3 months of the date of the informed consent form","FEMALE","40 Years",{"count":61,"type":21},330,"EXoPERT has developed a liquid biopsy-based in vitro diagnostic medical device that can diagnose cancer through blood. The in vitro diagnostic medical device for this clinical performance trial is a test device that applies a technology that measures Raman spectroscopic signals of extracellular vesicles in the blood and classifies high-risk and low-risk patients for breast cancer through artificial intelligence analysis.\n\nThe test device used in this clinical performance trial is expected to assist in the differential diagnosis of high-risk and low-risk breast cancer patients by developing a software algorithm for an in vitro diagnostic medical device for auxiliary diagnosis that classifies high-risk and low-risk breast cancer patients and confirming the clinical efficacy and safety of the device through this clinical performance trial.",[64],"Breast Neoplasm",[66,26,67],"Breast","Neoplasm","2026-01-06",{"date":70,"type":42},"2026-01-08",{"date":72,"type":42},"2024-10-16",{"date":74,"type":21},"2026-12-31",{"name":48,"class":49},""]