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

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ClinicalTrials.gov Identifier: NCT05199259
Recruitment Status : Recruiting
First Posted : January 20, 2022
Last Update Posted : July 11, 2023
Sponsor:
Information provided by (Responsible Party):
Helio Genomics

Study Description
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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.

Condition or disease Intervention/treatment
Liver Cirrhosis Liver Cancer HCC Hepatocellular Carcinoma Diagnostic Test: 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 Design
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Study Type : Observational
Estimated Enrollment : 1200 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Collection of Blood to Evaluate Epigenomics and Protein Biomarkers for the Detection of Hepatocellular Carcinoma
Actual Study Start Date : March 1, 2022
Estimated Primary Completion Date : January 2024
Estimated Study Completion Date : March 2024
Groups and Cohorts
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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.


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. Ascertain Reference Range(s) [ Time Frame: 1 - 9 months ]
    Ascertain reference range determination(s) for select CpG methylation sites

  3. Ascertain Sample Stability [ Time Frame: 1 - 9 months ]
    Sample stability under various shipping conditions


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05199259


Contacts
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Contact: Clinical Operations Manager, BSN, RN 626-350-0537 octavia@heliogenomics.com

Locations
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United States, California
Providence Facey Medical Foundation Recruiting
Mission Hills, California, United States, 91345
Contact: Clinical Research Associate       elyza.carvajal@providence.org   
Principal Investigator: Dilpirt Bagga, MD         
United States, Florida
Guardian Angel Research Center Recruiting
Tampa, Florida, United States, 33614
Contact: Study Coordinator    813-877-5320    lporrod@gmail.com   
Principal Investigator: Alejandro Diego, MD         
United States, Maryland
GI Research Mercy Medical Center Recruiting
Baltimore, Maryland, United States, 21202
Contact: Study Coordinator    410-843-2075    sshesadri@mdmercy.com   
Principal Investigator: Paul Thuluvath, MD         
United States, Texas
South Texas Research Institute Recruiting
Edinburg, Texas, United States, 78539
Contact: Site Manager    956-284-6353    margaret.leal@southtexasresearchinstitute.com   
Principal Investigator: Rashmee Patil, MD         
Texas Gastro Research Recruiting
El Paso, Texas, United States, 79936
Contact: Sub-I    915-529-0009      
Principal Investigator: Emmanuel Gorosphe, MD         
Impact Research Institute Recruiting
Waco, Texas, United States, 76710
Contact: Site Manager    254-294-4780    mrichardson@impactresearchtx.com   
Principal Investigator: Nadge Gunn, MD         
United States, Virginia
Digestive & Liver Disease Specialist Recruiting
Norfolk, Virginia, United States, 23502
Contact: Site Manager    757-961-1126    sharonb@glstva.com   
Principal Investigator: Whitney Brooks, MD         
Sponsors and Collaborators
Helio Genomics
Investigators
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Study Director: Taggert Helio Health
More Information
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Responsible Party: Helio Genomics
ClinicalTrials.gov Identifier: NCT05199259    
Other Study ID Numbers: HELIO-2021-US-002
First Posted: January 20, 2022    Key Record Dates
Last Update Posted: July 11, 2023
Last Verified: July 2023

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Hepatocellular
Liver Cirrhosis
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
 Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases
Fibrosis
Pathologic Processes