Multi-analyte Blood Test Clinical Trial

NCT05199259 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 1200

Last updated 2024-06-14

No results posted yet for this study

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

Interventions

DIAGNOSTIC_TEST

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.

Sponsors & Collaborators

  • Helio Genomics

    lead INDUSTRY

Principal Investigators

  • Taggert · Helio Health

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-03-01
Primary Completion
2025-01-31
Completion
2025-03-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05199259 on ClinicalTrials.gov