RecruitingLiver CirrhosisLiver CancerHCC
Multi-analyte Blood Test Clinical Trial
Eligible age
18+ yrs
Accepts
All genders
Locations
5 states
Healthy volunteers
No
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About this study
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.
Sponsor: Helio Genomics
You may qualify if…
- ✓ 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 ≥1 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.
You may not qualify if…
- ✕ 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.
Where it's recruiting
Source: ClinicalTrials.gov · NCT05199259 · last updated 2024-06-14