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RecruitingObservational

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

NCT ID: NCT05199259Sponsor: Helio GenomicsLast updated: 2024-06-14

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.

Arms & 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.

Outcome measures

Primary

  • Independent performance measure of sensitivity and specificity of a multi-analyte blood test

    The primary objective is to measure the performance (sensitivity and specificity) the multi-analyte blood Test for the detection of liver cancers in high-risk particiapnats.

    Time frame: 1 - 9 months

Secondary

  • To investigate potential endogenous and exogenous interfering substances of a multi-analyte blood test

    Time frame: 1 - 9 months

  • Ascertain Reference Range(s)

    Time frame: 1 - 9 months

  • Ascertain Sample Stability

    Time frame: 1 - 9 months

Eligibility criteria

Sex: AllAge: 18 Years and older
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

Study locations (7)

Providence Facey Medical Foundation

Mission Hills, California, 91345

Recruiting
Clinical Research Associate · Contact
Dilpirt Bagga, MD · Principal Investigator

Guardian Angel Research Center

Tampa, Florida, 33614

Recruiting
Study Coordinator · Contact
Alejandro Diego, MD · Principal Investigator

GI Research Mercy Medical Center

Baltimore, Maryland, 21202

Recruiting
Study Coordinator · Contact
Paul Thuluvath, MD · Principal Investigator

South Texas Research Institute

Edinburg, Texas, 78539

Recruiting
Rashmee Patil, MD · Principal Investigator

Texas Gastro Research

El Paso, Texas, 79936

Recruiting
Sub-I · Contact
Emmanuel Gorosphe, MD · Principal Investigator

Impact Research Institute

Waco, Texas, 76710

Recruiting
Nadge Gunn, MD · Principal Investigator

Digestive & Liver Disease Specialist

Norfolk, Virginia, 23502

Recruiting
Site Manager · Contact
Whitney Brooks, MD · Principal Investigator