Multi-analyte Blood Test Clinical Trial

Part of paid clinical trials in Escondido, 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

First listed
Jan 20, 2022
Start date
Mar 1, 2022
Status verified
Jul 2026
Primary completion
Dec 31, 2027
Completion
Dec 31, 2028

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
Gastroenterology and Liver InstituteEscondidoCalifornia02025
Yuri Guzman, MA
760-690-2800
[email protected]
Naveen Gara, MD (PRINCIPAL_INVESTIGATOR)
Providence Facey Medical FoundationMission HillsCalifornia91345
Clinical Research Associate
[email protected]
Dilpirt Bagga, MD (PRINCIPAL_INVESTIGATOR)
UF Hepatology Research at CTRBGainesvilleFlorida32610
Lauren Morelli, CCRC
[email protected]
352-273-9508
Morelli
Roniel Cabrera, MD (PRINCIPAL_INVESTIGATOR)
Guardian Angel Research CenterTampaFlorida33614
Study Coordinator
[email protected]
813-877-5320
Alejandro Diego, 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)

Find similar trials in Escondido, CA

By condition
Liver cancer
By specialty
OncologyGI oncologyHepatology
By research site
Gastroenterology and Liver Institute· Escondido, CAProvidence Facey Medical Foundation· Mission Hills, CAUF Hepatology Research at CTRB· Gainesville, FLGuardian Angel Research Center· Tampa, FLSouth Texas Research Institute· Edinburg, TXTexas Gastro Research· El Paso, TX

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