Multi-analyte Blood Test Clinical Trial

Part of paid clinical trials in Mission Hills, California.

Sponsor
Helio Genomics
Study ID
NCT05199259
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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.

Study Details

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.

Key Dates

Start date
Mar 1, 2022
Status verified
Jun 2024
Primary completion
Jan 31, 2025
Completion
Mar 31, 2025

Study Design

Enrollment
1,200 participants (estimated)

Arms

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

Primary Outcome Measure

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

Central Contacts

Locations (7)

FacilityCityStateZIPSite coordinators
Providence Facey Medical FoundationMission HillsCalifornia91345
Clinical Research Associate
[email protected]
Dilpirt Bagga, MD (PRINCIPAL_INVESTIGATOR)
Guardian Angel Research CenterTampaFlorida33614
Study Coordinator
[email protected]
813-877-5320
Alejandro Diego, MD (PRINCIPAL_INVESTIGATOR)
GI Research Mercy Medical CenterBaltimoreMaryland21202
Study Coordinator
[email protected]
410-843-2075
Paul Thuluvath, MD (PRINCIPAL_INVESTIGATOR)
South Texas Research InstituteEdinburgTexas78539
Site Manager
[email protected]
956-284-6353
Rashmee Patil, MD (PRINCIPAL_INVESTIGATOR)
Texas Gastro ResearchEl PasoTexas79936
Sub-I
915-529-0009
Emmanuel Gorosphe, MD (PRINCIPAL_INVESTIGATOR)
Impact Research InstituteWacoTexas76710
Site Manager
[email protected]
254-294-4780
Nadge Gunn, MD (PRINCIPAL_INVESTIGATOR)
Digestive & Liver Disease SpecialistNorfolkVirginia23502
Site Manager
[email protected]
757-961-1126
Whitney Brooks, MD (PRINCIPAL_INVESTIGATOR)

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By research site
Providence Facey Medical Foundation· Mission Hills, CAGuardian Angel Research Center· Tampa, FLGI Research Mercy Medical Center· Baltimore, MDSouth Texas Research Institute· Edinburg, TXTexas Gastro Research· El Paso, TXImpact Research Institute· Waco, TX

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