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Multi-analyte Blood Test Clinical Trial

Recruitingn/aAges 18 Years - anyAllHelio Genomics
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * Age 18 years or older. * Males and Females. * Having cirrhosis or meeting the AASLD guidelines for HCC * surveillance. * Clinically diagnosed with HCC or negative for HCC following disease * surveillance. * HCC positive Group: Subject has a recent (within 6 months of enrollment) clinically diagnosed, untreated hepatocellular carcinoma as defined by at least one โ‰ฅ1 cm lesion exhibiting arterial phase hyperenhancement in combination with washout appearance and/or capsule by 4 phase CT scan or multiphase contrast enhanced MRI or biopsy is positive for HCC. * 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. * Sub-Group 1 (approximately 450 subjects) - negative by CT or MRI (No lesion, LR-1 or LR-2) * Sub-Group 2 (approximately 450 subjects) - negative by ultrasound Exclusion Criteria: * Subjects that are unwilling or unable to sign the Informed Consent Form will be excluded. * 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). * Chemotherapy and/or radiation therapy within 5 years prior to enrollment/sample collection. * Prior or current treatment with sorafenib, regorafenib, or other treatment indicated for HCC. * Prior treatment with a DNA methyltransferase inhibitor such as with Vidaza (azacitidine) or Dacogen (decitabine) * Any HCC treatment prior to enrollment/blood sample collection (e.g., surgery, ablation, embolization, pharmacotherapy, radiotherapy, liver transplant or other treatment indicated for HCC). * IV contrast (e.g., CT and MRI) within 1 day \[or 24 hours\] of blood collection. * Less than 3 days between fine needle aspiration (FNA) of target pathology and blood collection. * Less than 7 days between biopsy (other than FNA) of target pathology and blood collection. * 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. * For HCC negative subjects, patients with a prior diagnosis of HCC are also excluded. * Subjects that are pregnant will be exclude
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What it tests

  • Multi-analyte Blood Test
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Where

7 sites
Gastroenterology and Liver Institute
Escondido, United States
Providence Facey Medical Foundation
Mission Hills, United States
UF Hepatology Research at CTRB
Gainesville, United States
Guardian Angel Research Center
Tampa, United States
South Texas Research Institute
Edinburg, United States
Texas Gastro Research
El Paso, United States
Impact Research Institute
Waco, United States
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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