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

Recruiting

• Conditions: Cancer; COPD; Liver Cirrhosis; Chronic Hepatitis; Hepatitis B; Hepatitis C; Diabetes

• Registration Number: NCT05181826
• Lead Sponsor: Helio Genomics

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.

Detailed 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.

Study Timeline

• Study Start: 2019-05-21
• Study First Submitted: 2021-12-17
• Study First Submitted QC: 2022-01-05
• Study First Posted: 2022-01-06
• Status Verified: 2023-07
• Last Update Submitted: 2024-06-13
• Last Update Posted: 2024-06-14
• Primary Completion: 2025-09
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1200

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.

Secondary Outcome Measures

Name	Time	Method
Ascertain Reference Range(s)	1 Month	Ascertain reference range determination(s) for select CpG methylation sites
To investigate potential endogenous and exogenous interfering substances of a multi-analyte blood test	1 Month	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.
Ascertain Sample Stability	1 Month	Sample stability under various shipping conditions

Trial Locations

Locations (7)

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

Allina Health, Virginia Piper Cancer Institute; 🇺🇸 Coon Rapids, Minnesota, United States

Torrance Memorial Physician Network - Cancer Care; 🇺🇸 Redondo Beach, California, United States

Liver Center of Texas; 🇺🇸 Dallas, Texas, United States

Methodist Hospital; 🇺🇸 Richardson, Texas, United States