[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Helio Genomics\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":64},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,42],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"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":20,"type":21},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.",[25,26,27,28],"Liver Cirrhosis","Liver Cancer","HCC","Hepatocellular Carcinoma","RECRUITING","2026-07-09",{"date":32,"type":33},"2026-07-10","ACTUAL",{"date":35,"type":33},"2022-03-01",{"date":37,"type":21},"2028-12",{"name":39,"class":40},"Helio Genomics","INDUSTRY",7,{"id":43,"slug":44,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":46,"acronym":47,"eligibilityCriteria":48,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":49,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":50,"conditions":51,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":58,"startDateStruct":59,"completionDateStruct":61,"leadSponsor":63,"locationsCount":41},"100453229","collection-of-blood-from-healthy-patients-patients-with-benign-disease-and-patients-with-cancer-100453229","NCT05181826","Collection of Blood From Healthy Patients, Patients With Benign Disease and Patients With Cancer","ELITE","Inclusion Criteria:\n\n2.1.1 Age 18 years or older.\n\n2.1.2 A diagnosis of cancer, cancer remission, benign disease (benign tumor, diabetes, liver cirrhosis, chronic hepatitis B or hepatitis C virus infection, Chronic obstructive pulmonary disease, etc.) or apparently healthy volunteers. .\n\nExclusion Criteria:\n\n2.2.1 Patients that are unwilling or unable to sign the Informed Consent Form will be excluded.\n\n2.2.2 Approximately 50 mL of blood will be drawn from participants within an 8-week period under this protocol. Patients that have already given 50 mL of blood within this time frame will be excluded.",{"count":20,"type":21},"To acquire blood samples from subjects for various purposes, including: i) determining the sensitivity and specificity of select DNA methylation markers for the detection of various types of cancer, ii) identifying benign conditions that may induce false positive or false negative results, and iii) defining the effects of potential interfering substances, such as chemotherapy drugs.",[52,25,53,54,55,56,57],"Cancer","Chronic Hepatitis","Hepatitis B","Hepatitis C","Diabetes","COPD",{"date":32,"type":33},{"date":60,"type":33},"2019-05-21",{"date":62,"type":21},"2028-01",{"name":39,"class":40},""]