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

Cancer Clinical Trial

— ELITE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05181826
• Other study ID #: 001-2018
• Status: Recruiting
• Start date: May 21, 2019
• Est. completion date: December 2025

Study information

• Verified date: July 2023
• Source: Helio Genomics
• Contact: Clinical Operations Manager
• Phone: 6263500537
• Email: octavia[@]heliogenomics.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

Whole blood, plasma, and/or serum specimens will be collected from patients with active cancer, patients in cancer remission, patients diagnosed with benign disease, and healthy volunteers. These blood samples will be used to perform various studies to determine the utility of select DNA methylation markers for cancer diagnostic or prognostic indications.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1200
• Est. completion date: December 2025
• Est. primary completion date: September 2025
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cancer
• Chronic Hepatitis
• COPD
• Diabetes
• Hepatitis
• Hepatitis A
• Hepatitis B
• Hepatitis C
• Liver Cirrhosis

Intervention

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

Locations

Country	Name	City	State
United States	Allina Health, Virginia Piper Cancer Institute	Coon Rapids	Minnesota
United States	Liver Center of Texas	Dallas	Texas
United States	Virginia Piper Cancer Institute Mercy Hospital-Unity Campus	Fridley	Minnesota
United States	Methodist LeBonheur Healthcare	Memphis	Tennessee
United States	VPCI Oncology Research	Minneapolis	Minnesota
United States	Torrance Memorial Physician Network - Cancer Care	Redondo Beach	California
United States	Methodist Hospital	Richardson	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Helio Genomics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Independent performance measure of sensitivity and specificity of a multi-analyte blood test	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.	1 month
Secondary	To investigate potential endogenous and exogenous interfering substances of a multi-analyte blood test	To investigate potential endogenous and exogenous interfering substances of a multi-analyte blood test for the detection of liver cancers within healthy subjects, subjects diagnosed with active cancer, subjects in cancer remission, and subjects diagnosed with a benign disease.	1 Month
Secondary	Ascertain Reference Range(s)	Ascertain reference range determination(s) for select CpG methylation sites	1 Month
Secondary	Ascertain Sample Stability	Sample stability under various shipping conditions	1 Month