Multi-analyte Blood Test Clinical Trial (LIVER-1)

July 10, 2023 updated by: Helio Genomics

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

1200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • California
      • Mission Hills, California, United States, 91345
        • Recruiting
        • Providence Facey Medical Foundation
        • Contact:
        • Principal Investigator:
          • Dilpirt Bagga, MD
    • Florida
      • Tampa, Florida, United States, 33614
        • Recruiting
        • Guardian Angel Research Center
        • Contact:
        • Principal Investigator:
          • Alejandro Diego, MD
    • Maryland
      • Baltimore, Maryland, United States, 21202
        • Recruiting
        • GI Research Mercy Medical Center
        • Principal Investigator:
          • Paul Thuluvath, MD
        • Contact:
    • Texas
      • Edinburg, Texas, United States, 78539
      • El Paso, Texas, United States, 79936
        • Recruiting
        • Texas Gastro Research
        • Contact:
          • Sub-I
          • Phone Number: 915-529-0009
        • Principal Investigator:
          • Emmanuel Gorosphe, MD
      • Waco, Texas, United States, 76710
        • Recruiting
        • Impact Research Institute
        • Contact:
        • Principal Investigator:
          • Nadge Gunn, MD
    • Virginia
      • Norfolk, Virginia, United States, 23502
        • Recruiting
        • Digestive & Liver Disease Specialist
        • Contact:
        • Principal Investigator:
          • Whitney Brooks, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

The subjects 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 subjects in sub-group 2 will receive a confirmatory ultrasound approximately 6 months (between 5 to 7 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. The blood specimens will be shipped to a clinical diagnostic laborator

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
HCC positive Group
Multi-analyte blood test screen in participants with a recent confirmed untreated diagnosis of HCC by CT scan, MRI or biopsy.
Diagnostic test: Multi-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.
HCC negative Group: Sub-Group 1
Multi-analyte blood test screen in participants with a recent confirmed negative diagnosis of HCC by CT or MRI (No lesion, LR-1 or LR-2)
Diagnostic test: Multi-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.
HCC negative Group: Sub-Group 2
Multi-analyte blood test screen in participants with a recent confirmed negative diagnosis of HCC by ultrasound. Participants will be scheduled for a 6 month visit (at least 5 months but no more 9 months form enrollment) for a confirmatory ultrasound.
Diagnostic test: Multi-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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Independent performance measure of sensitivity and specificity of a multi-analyte blood test
Time Frame: 1 - 9 months
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.
1 - 9 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To investigate potential endogenous and exogenous interfering substances of a multi-analyte blood test
Time Frame: 1 - 9 months
To investigate potential endogenous and exogenous interfering substances of a multi-analyte blood test for the detection of liver cancers within healthy subjects, subjects diagnosed with active cancer, subjects in cancer remission, and subjects diagnosed with a benign disease.
1 - 9 months
Ascertain Reference Range(s)
Time Frame: 1 - 9 months
Ascertain reference range determination(s) for select CpG methylation sites
1 - 9 months
Ascertain Sample Stability
Time Frame: 1 - 9 months
Sample stability under various shipping conditions
1 - 9 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Helio Genomics

Investigators

  • Study Director: Taggert, Helio Health

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2022

Primary Completion (Estimated)

January 1, 2024

Study Completion (Estimated)

March 1, 2024

Study Registration Dates

First Submitted

December 15, 2021

First Submitted That Met QC Criteria

January 5, 2022

First Posted (Actual)

January 20, 2022

Study Record Updates

Last Update Posted (Actual)

July 11, 2023

Last Update Submitted That Met QC Criteria

July 10, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HELIO-2021-US-002

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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