Recruiting

Observational Study

Sponsor:

Helio Genomics

Code:

NCT05181826

Conditions

Cancer

Liver Cirrhosis

Chronic Hepatitis

Hepatitis B

Hepatitis C

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Multi-analyte Blood Test

Study Details

Brief 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.

Conditions

Cancer

Liver Cirrhosis

Chronic Hepatitis

Hepatitis B

Hepatitis C

Study ID

NCT05181826

Start date

May 21, 2019

Status verified date

Jul, 2026

Completion date

Jan, 2028

Anticipated

Primary completion date

Dec, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

1200 participants

Anticipated

Interventions and Outcome Measures

Interventions

Multi-analyte Blood Test

Intend for the qualitative detection of DNA methylation markers for the detection of various types of cancer

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Clinical Operations Manager

6263500537octavia@heliogenomics.com

Locations

Allina Health, Virginia Piper Cancer Institute

Recruiting

Coon Rapids, Minnesota, United States, 55433

Contacts

Kathryn Gruetzman

763-236-0814kathryn.gruetzman@allina.com

Principal Investigator:

Micheala Tsai, MD

Virginia Piper Cancer Institute Mercy Hospital-Unity Campus

Recruiting

Fridley, Minnesota, United States, 55432

Contacts

Lynne Schroeder

lynne.schroeder@allina.com

Principal Investigator:

Micheala Tsai

VPCI Oncology Research

Recruiting

Minneapolis, Minnesota, United States, 55407

Contacts

Kelsey Froemming

kelsey.froemming@allina.com

Principal Investigator:

Micheala Tsai, MD

Methodist LeBonheur Healthcare

Recruiting

Memphis, Tennessee, United States, 38104

Contacts

Carol Jones

901-516-8078carol.jones@mlh.org

Principal Investigator:

Jiten Kothadia, MD

Liver Center of Texas

Recruiting

Dallas, Texas, United States, 75234

Contacts

Ariela Moreno

ariela@livercenteroftexas.com

Principal Investigator:

Abdullah Mubarak, MD

Methodist Hospital

Recruiting

Richardson, Texas, United States, 75082

Contacts

Araceli Torres

aracelitorres@mhd.com

Principal Investigator:

Rohan Jeyarajah, MD

More Information

Sponsor

Helio Genomics

Last update posted

Jul 10, 2026

Last verified

Jul, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Helio Genomics on 2026-07-10.