Multi-analyte Blood Test Clinical Trial

NCT05199259 | Recruiting FDA Device

• 1 other identifier: HELIO-2021-US-002
• Study Type: observational
• Target: 1,200
• Locations: 1 country
• Sites: 7

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

Outcome Measures

Primary Outcomes (1)

• 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.

  1 - 9 months

Secondary Outcomes (3)

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

  1 - 9 months

• Ascertain Reference Range(s)

  1 - 9 months

• Ascertain Sample Stability

  1 - 9 months

Study Arms (3)

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

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

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

Interventions

Multi-analyte Blood Test DIAGNOSTIC_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; HCC negative Group: Sub-Group 2; HCC positive Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Helio Genomics: lead

Study Sites (7)

Providence Facey Medical Foundation

Mission Hills, California, 91345, United States

RECRUITING

Guardian Angel Research Center

Tampa, Florida, 33614, United States

RECRUITING

GI Research Mercy Medical Center

Baltimore, Maryland, 21202, United States

RECRUITING

South Texas Research Institute

Edinburg, Texas, 78539, United States

RECRUITING

Texas Gastro Research

El Paso, Texas, 79936, United States

RECRUITING

Impact Research Institute

Waco, Texas, 76710, United States

RECRUITING

Digestive & Liver Disease Specialist

Norfolk, Virginia, 23502, United States

RECRUITING

MeSH Terms

Conditions

Liver Cirrhosis; Liver Neoplasms; Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Study Officials

• Taggert

  Helio Health

  STUDY DIRECTOR

Central Study Contacts

Clinical Operations Manager, BSN, RN

CONTACT

626-350-0537; octavia@heliogenomics.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 15, 2021
• First Posted: January 20, 2022
• Study Start: March 1, 2022
• Primary Completion: January 1, 2025
• Study Completion: March 1, 2025
• Last Updated: June 14, 2024

Record last verified: 2024-06

Locations

US (7)