RecruitingNCT05199259

Multi-analyte Blood Test Clinical Trial

Collection of Blood to Evaluate Epigenomics and Protein Biomarkers for the Detection of Hepatocellular Carcinoma

Sponsor

Helio Genomics

Enrollment

1,200 participants

Start Date

Mar 1, 2022

Study Type

OBSERVATIONAL

Conditions

Liver Cancer Hepatocellular Carcinoma Liver Cirrhosis HCC

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria10

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 Criteria12

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

Interventions

DIAGNOSTIC_TESTMulti-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.