RECRUITING

Multi-analyte Blood Test Clinical Trial

Conditions

Liver Cirrhosis Liver Cancer HCC Hepatocellular Carcinoma

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2022-03-01

Study Completion:2025-03

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05199259

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.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Not specified

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	* 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

Inclusion Criteria

Exclusion 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

* 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

Study Contact

Clinical Operations Manager, BSN, RN

CONTACT

626-350-0537

octavia@heliogenomics.com

Principal Investigator

Taggert

STUDY_DIRECTOR

Helio Health

Study Locations (Sites)

Providence Facey Medical Foundation

Mission Hills, California, 91345

United States

Guardian Angel Research Center

Tampa, Florida, 33614

United States

GI Research Mercy Medical Center

Baltimore, Maryland, 21202

United States

South Texas Research Institute

Edinburg, Texas, 78539

United States

Texas Gastro Research

El Paso, Texas, 79936

United States

Impact Research Institute

Waco, Texas, 76710

United States

Digestive & Liver Disease Specialist

Norfolk, Virginia, 23502

United States

Collaborators and Investigators

Sponsor: Helio Genomics

Taggert, STUDY_DIRECTOR, 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 Registration Dates

Study Start Date2022-03-01

Study Completion Date2025-03

Study Record Updates

Study Start Date2022-03-01

Study Completion Date2025-03

Terms related to this study

Additional Relevant MeSH Terms

Liver Cirrhosis
Liver Cancer
HCC
Hepatocellular Carcinoma