[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100454570":3},{"organization":4,"armGroups":7,"interventions":22,"overallOfficials":28,"centralContacts":33,"locations":39,"responsibleParty":160,"collaborators":10,"id":162,"slug":163,"hasResults":164,"nctId":165,"briefTitle":166,"officialTitle":167,"acronym":168,"eligibilityCriteria":169,"healthyVolunteers":164,"sex":170,"minAge":171,"maxAge":10,"enrollmentInfo":172,"targetDuration":10,"studyType":175,"phases":10,"briefSummary":176,"conditions":177,"keywords":10,"overallStatus":42,"whyStopped":10,"lastUpdateSubmitDate":182,"lastUpdatePostDateStruct":183,"startDateStruct":186,"completionDateStruct":188,"leadSponsor":190,"locationsCount":191},{"fullName":5,"class":6},"Helio Genomics","INDUSTRY",[8,14,18],{"label":9,"type":10,"description":11,"interventionNames":12},"HCC positive Group",null,"Multi-analyte blood test screen in participants with a recent confirmed untreated diagnosis of HCC by CT scan, MRI or biopsy.",[13],"Diagnostic Test: Multi-analyte Blood Test",{"label":15,"type":10,"description":16,"interventionNames":17},"HCC negative Group: Sub-Group 1","Multi-analyte blood test screen in participants with a recent confirmed negative diagnosis of HCC by CT or MRI (No lesion, LR-1 or LR-2)",[13],{"label":19,"type":10,"description":20,"interventionNames":21},"HCC negative Group: Sub-Group 2","Multi-analyte blood test screen in participants with a recent confirmed negative diagnosis of HCC by ultrasound. Participants will be scheduled for a 6 month visit (at least 5 months but no more 9 months form enrollment) for a confirmatory ultrasound.",[13],[23],{"type":24,"name":25,"description":26,"armGroupLabels":27,"otherNames":10},"DIAGNOSTIC_TEST","Multi-analyte Blood Test","A clinical diagnostic test based upon the detection and quantification of DNA methylation markers in cell-free DNA (cfDNA) isolated from plasma and of tumor-specific proteins isolated from serum.",[15,19,9],[29],{"name":30,"affiliation":31,"role":32},"Taggert","Helio Health","STUDY_DIRECTOR",[34],{"name":35,"role":36,"phone":37,"phoneExt":10,"email":38},"Clinical Operations Manager, BSN, RN","CONTACT","626-350-0537","octavia@heliogenomics.com",[40,63,78,97,113,130,145],{"facility":41,"status":42,"city":43,"state":44,"zip":45,"country":46,"countryCode":47,"cosmosGeoPoint":48,"geoPoint":53,"contacts":54},"Gastroenterology and Liver Institute","RECRUITING","Escondido","California","02025","United States","US",{"type":49,"coordinates":50},"Point",[51,52],-117.08642,33.11921,{"lat":52,"lon":51},[55,58,60],{"name":56,"role":36,"phone":57,"phoneExt":10,"email":10},"Yuri Guzman, MA","760-690-2800",{"name":10,"role":36,"phone":10,"phoneExt":10,"email":59},"yguzman@giandliver.org",{"name":61,"role":62,"phone":10,"phoneExt":10,"email":10},"Naveen Gara, MD","PRINCIPAL_INVESTIGATOR",{"facility":64,"status":42,"city":65,"state":44,"zip":66,"country":46,"countryCode":47,"cosmosGeoPoint":67,"geoPoint":71,"contacts":72},"Providence Facey Medical Foundation","Mission Hills","91345",{"type":49,"coordinates":68},[69,70],-120.43683,34.68609,{"lat":70,"lon":69},[73,76],{"name":74,"role":36,"phone":10,"phoneExt":10,"email":75},"Clinical Research Associate","elyza.carvajal@providence.org",{"name":77,"role":62,"phone":10,"phoneExt":10,"email":10},"Dilpirt Bagga, MD",{"facility":79,"status":42,"city":80,"state":81,"zip":82,"country":46,"countryCode":47,"cosmosGeoPoint":83,"geoPoint":87,"contacts":88},"UF Hepatology Research at CTRB","Gainesville","Florida","32610",{"type":49,"coordinates":84},[85,86],-82.32483,29.65163,{"lat":86,"lon":85},[89,93,95],{"name":90,"role":36,"phone":91,"phoneExt":10,"email":92},"Lauren Morelli, CCRC","352-273-9508","Lauren.Morelli@medicine.ufl.edu",{"name":94,"role":36,"phone":10,"phoneExt":10,"email":10},"Morelli",{"name":96,"role":62,"phone":10,"phoneExt":10,"email":10},"Roniel Cabrera, MD",{"facility":98,"status":42,"city":99,"state":81,"zip":100,"country":46,"countryCode":47,"cosmosGeoPoint":101,"geoPoint":105,"contacts":106},"Guardian Angel Research Center","Tampa","33614",{"type":49,"coordinates":102},[103,104],-82.45843,27.94752,{"lat":104,"lon":103},[107,111],{"name":108,"role":36,"phone":109,"phoneExt":10,"email":110},"Study Coordinator","813-877-5320","lporrod@gmail.com",{"name":112,"role":62,"phone":10,"phoneExt":10,"email":10},"Alejandro Diego, MD",{"facility":114,"status":42,"city":115,"state":116,"zip":117,"country":46,"countryCode":47,"cosmosGeoPoint":118,"geoPoint":122,"contacts":123},"South Texas Research Institute","Edinburg","Texas","78539",{"type":49,"coordinates":119},[120,121],-98.16334,26.30174,{"lat":121,"lon":120},[124,128],{"name":125,"role":36,"phone":126,"phoneExt":10,"email":127},"Site Manager","956-284-6353","margaret.leal@southtexasresearchinstitute.com",{"name":129,"role":62,"phone":10,"phoneExt":10,"email":10},"Rashmee Patil, MD",{"facility":131,"status":42,"city":132,"state":116,"zip":133,"country":46,"countryCode":47,"cosmosGeoPoint":134,"geoPoint":138,"contacts":139},"Texas Gastro Research","El Paso","79936",{"type":49,"coordinates":135},[136,137],-106.48693,31.75872,{"lat":137,"lon":136},[140,143],{"name":141,"role":36,"phone":142,"phoneExt":10,"email":10},"Sub-I","915-529-0009",{"name":144,"role":62,"phone":10,"phoneExt":10,"email":10},"Emmanuel Gorosphe, MD",{"facility":146,"status":42,"city":147,"state":116,"zip":148,"country":46,"countryCode":47,"cosmosGeoPoint":149,"geoPoint":153,"contacts":154},"Impact Research Institute","Waco","76710",{"type":49,"coordinates":150},[151,152],-97.14667,31.54933,{"lat":152,"lon":151},[155,158],{"name":125,"role":36,"phone":156,"phoneExt":10,"email":157},"254-294-4780","mrichardson@impactresearchtx.com",{"name":159,"role":62,"phone":10,"phoneExt":10,"email":10},"Nadge Gunn, MD",{"type":161,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100454570","multi-analyte-blood-test-clinical-trial-100454570",false,"NCT05199259","Multi-analyte Blood Test Clinical Trial","Collection of Blood to Evaluate Epigenomics and Protein Biomarkers for the Detection of Hepatocellular Carcinoma","LIVER-1","Inclusion Criteria:\n\n* Age 18 years or older.\n* Males and Females.\n* Having cirrhosis or meeting the AASLD guidelines for HCC\n* surveillance.\n* Clinically diagnosed with HCC or negative for HCC following disease\n* surveillance.\n* HCC positive Group: Subject has a recent (within 6 months of enrollment) clinically diagnosed, untreated hepatocellular carcinoma as defined by at least one ≥1 cm lesion exhibiting arterial phase hyperenhancement in combination with washout appearance and\u002For capsule by 4 phase CT scan or multiphase contrast enhanced MRI or biopsy is positive for HCC.\n* HCC negative Group: Non-cancer, at-risk subjects with chronic liver disease undergoing routine imaging surveillance for HCC, where the definitive lack of HCC within 3 months prior to enrollment has been verified by negative imaging, for HCC. No more than 200 subjects without cirrhosis can be enrolled in this group.\n* Sub-Group 1 (approximately 450 subjects) - negative by CT or MRI (No lesion, LR-1 or LR-2)\n* Sub-Group 2 (approximately 450 subjects) - negative by ultrasound\n\nExclusion Criteria:\n\n* Subjects that are unwilling or unable to sign the Informed Consent Form will be excluded.\n* Known cancer diagnosis of a cancer other than HCC within the past 5 years (with the exceptions of basal cell or squamous cell skin cancers).\n* Chemotherapy and\u002For radiation therapy within 5 years prior to enrollment\u002Fsample collection.\n* Prior or current treatment with sorafenib, regorafenib, or other treatment indicated for HCC.\n* Prior treatment with a DNA methyltransferase inhibitor such as with Vidaza (azacitidine) or Dacogen (decitabine)\n* Any HCC treatment prior to enrollment\u002Fblood sample collection (e.g., surgery, ablation, embolization, pharmacotherapy, radiotherapy, liver transplant or other treatment indicated for HCC).\n* IV contrast (e.g., CT and MRI) within 1 day \\[or 24 hours\\] of blood collection.\n* Less than 3 days between fine needle aspiration (FNA) of target pathology and blood collection.\n* Less than 7 days between biopsy (other than FNA) of target pathology and blood collection.\n* Any condition the Investigator believes would interfere with his or her ability to provide informed consent, comply with the study protocol, which might confound the interpretation of the study results or put the person at undue risk.\n* For HCC negative subjects, patients with a prior diagnosis of HCC are also excluded.\n* Subjects that are pregnant will be exclude","ALL","18 Years",{"count":173,"type":174},1200,"ESTIMATED","OBSERVATIONAL","The objective of this study is the acquisition of whole blood samples and serum samples from participants with untreated Hepatocellular Carcinoma (HCC) and subjects undergoing Hepatocellular Carcinoma (HCC) surveillance. These samples will be used for research purposes to develop and validate the Helio multi-analyte blood test.",[178,179,180,181],"Liver Cirrhosis","Liver Cancer","HCC","Hepatocellular Carcinoma","2026-07-09",{"date":184,"type":185},"2026-07-10","ACTUAL",{"date":187,"type":185},"2022-03-01",{"date":189,"type":174},"2028-12",{"name":5,"class":6},7]