Official Title
Collection of Blood to Evaluate Epigenomics and Protein Biomarkers for the Detection of Hepatocellular Carcinoma
Brief Title
Multi-analyte Blood Test Clinical Trial
Protocol ID
NCT05199259
Lead Sponsor
Helio Genomics
Brief Summary
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.
Detailed Description
This study pertains to the collection of whole blood and serum specimens from
participants undergoing Hepatocellular Carcinoma (HCC) surveillance. The participants
will fall into two main groups, subjects diagnosed with HCC (HCC positive Group) or
subjects without HCC (HCC negative Group).
The HCC negative Group will be further divided into two sub-groups based on whether the
absence of HCC has been determined using CT or MRI procedures (Sub-group 1) or ultrasound
(Sub-group 2). Only the participants in sub-group 2 will receive a confirmatory
ultrasound approximately 6 months (between 5 to 9 months) after enrollment to confirm the
absence of HCC (6-month visit). This additional imaging study is necessary due to the low
sensitivity of abdominal ultrasound to detect HCC lesions.
Participants will be screened for eligibility to participate in the study based on their
medical history and records. Participants with a recent confirmed Collection of Blood to
Evaluate Epigenomics and Protein Biomarkers for the detection of Hepatocellular Carcinoma
diagnosis of HCC (within 6 months of enrollment) may be enrolled in such way to ensure
the cases are representative of the major liver disease etiologies in the surveillance
population in the United States.
Specifically, the following causes of cirrhosis will be selected:
- Alcoholic steatohepatitis (ASH);
- Hepatitis B virus (HBV);
- Hepatitis C virus (HCV);
- Non-alcoholic fatty liver disease (NAFLD);
- Other genetic conditions that cause cirrhosis (i.e., hemochromatosis)
These blood samples will be used to perform various studies to determine the utility of
selected DNA methylation and protein markers for the liver cancer diagnostic test.
Study Period
Enrollment Count
1,200 participants
Eligibility Criteria
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 ≥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.
- 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
Filters
Liver Cirrhosis
Liver Cancer
HCC
Hepatocellular Carcinoma
RECRUITING
ADULT
OLDER_ADULT