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Clinical Trials in the USA / NCT05181826
Recruiting Observational

Collection of Blood From Healthy Patients, Patients With Benign Disease and Patients With Cancer

NCT05181826 · tracked via the Priya Life Science USA tracker
Sponsor
Helio Genomics
Phase
Observational
Started
2019-05-21
Last updated
2026-07-10

Condition(s) studied

CancerLiver CirrhosisChronic HepatitisHepatitis BHepatitis CDiabetesCOPD

Investigational drug(s) / intervention(s)

Multi-analyte Blood Test

Multi-analyte Blood Test: Intend for the qualitative detection of DNA methylation markers for the detection of various types of cancer

Study summary

To acquire blood samples from subjects for various purposes, including: i) determining the sensitivity and specificity of select DNA methylation markers for the detection of various types of cancer, ii) identifying benign conditions that may induce false positive or false negative results, and iii) defining the effects of potential interfering substances, such as chemotherapy drugs.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: 2.1.1 Age 18 years or older. 2.1.2 A diagnosis of cancer, cancer remission, benign disease (benign tumor, diabetes, liver cirrhosis, chronic hepatitis B or hepatitis C virus infection, Chronic obstructive pulmonary disease, etc.) or apparently healthy volunteers. . Exclusion Criteria: 2.2.1 Patients that are unwilling or unable to sign the Informed Consent Form will be excluded. 2.2.2 Approximately 50 mL of blood will be drawn from participants within an 8-week period under this protocol. Patients that have already given 50 mL of blood within this time frame will be excluded.

Primary outcome measure(s)

  • Independent performance measure of sensitivity and specificity of a multi-analyte blood test — 1 month
    The primary objective is to measure the performance (sensitivity and specificity) the multi-analyte blood Test for the detection of liver cancers in healthy subjects, subjects diagnosed with active cancer, subjects in cancer remission, and subjects diagnosed with a benign disease.

Trial sites (7)

FacilityCityRegionStatus
Torrance Memorial Physician Network - Cancer Care Redondo Beach California Active Not Recruiting
Allina Health, Virginia Piper Cancer Institute Coon Rapids Minnesota Recruiting
Virginia Piper Cancer Institute Mercy Hospital-Unity Campus Fridley Minnesota Recruiting
VPCI Oncology Research Minneapolis Minnesota Recruiting
Methodist LeBonheur Healthcare Memphis Tennessee Recruiting
Liver Center of Texas Dallas Texas Recruiting
Methodist Hospital Richardson Texas Recruiting

More Helio Genomics trials in the USA

Clinical Trial Multi-analyte Blood Test Active, not recruiting
Multi-analyte Blood Test Clinical Trial Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05181826 on ClinicalTrials.gov ↗ ← All trials in the USA