Recruiting

Blood TestMulti-analyte Blood Test Clinical Trial

Sponsor:

Helio Genomics

Code:

NCT05199259

Conditions

Liver Cirrhosis

Liver Cancer

HCC

Hepatocellular Carcinoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Multi-analyte Blood Test

Study Details

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.

Conditions

Liver Cirrhosis

Liver Cancer

HCC

Hepatocellular Carcinoma

Study ID

NCT05199259

Start date

Mar 1, 2022

Status verified date

Jul, 2026

Completion date

Dec, 2028

Anticipated

Primary completion date

Dec, 2027

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

1200 participants

Anticipated

Interventions and Outcome Measures

Arms

HCC positive Group

Multi-analyte blood test screen in participants with a recent confirmed untreated diagnosis of HCC by CT scan, MRI or biopsy.

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)

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.

Interventions

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.

Primary outcome measure

Independent performance measure of sensitivity and specificity of a multi-analyte blood test [ Time Frame: 1 - 9 months ]

Central Contacts and Locations

Central contacts

Clinical Operations Manager, BSN, RN

626-350-0537 octavia@heliogenomics.com

Locations

Gastroenterology and Liver Institute

Recruiting

Escondido, California, United States, 02025

Contacts

Yuri Guzman, MA

760-690-2800

yguzman@giandliver.org

Principal Investigator:

Naveen Gara, MD

Providence Facey Medical Foundation

Recruiting

Mission Hills, California, United States, 91345

Contacts

Clinical Research Associate

elyza.carvajal@providence.org

Principal Investigator:

Dilpirt Bagga, MD

UF Hepatology Research at CTRB

Recruiting

Gainesville, Florida, United States, 32610

Contacts

Lauren Morelli, CCRC

352-273-9508 Lauren.Morelli@medicine.ufl.edu

Principal Investigator:

Roniel Cabrera, MD

Guardian Angel Research Center

Recruiting

Tampa, Florida, United States, 33614

Contacts

Study Coordinator

813-877-5320 lporrod@gmail.com

Principal Investigator:

Alejandro Diego, MD

South Texas Research Institute

Recruiting

Edinburg, Texas, United States, 78539

Contacts

Site Manager

956-284-6353 margaret.leal@southtexasresearchinstitute.com

Principal Investigator:

Rashmee Patil, MD

Texas Gastro Research

Recruiting

El Paso, Texas, United States, 79936

Contacts

Sub-I

915-529-0009

Principal Investigator:

Emmanuel Gorosphe, MD

Impact Research Institute

Recruiting

Waco, Texas, United States, 76710

Contacts

Site Manager

254-294-4780 mrichardson@impactresearchtx.com

Principal Investigator:

Nadge Gunn, MD

More Information

Sponsor

Helio Genomics

Last update posted

Jul 10, 2026

Last verified

Jul, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Helio Genomics on 2026-07-10.