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

Helio Genomics1,200 enrolled

Overview

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.

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 Type

OBSERVATIONAL

Enrollment

1,200

Conditions

Cancer Liver Cirrhosis Chronic Hepatitis Hepatitis B Hepatitis C Diabetes COPD

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (7)

Torrance Memorial Physician Network - Cancer Care

Redondo Beach, California, United States

ACTIVE_NOT_RECRUITING

Allina Health, Virginia Piper Cancer Institute

Coon Rapids, Minnesota, United States

RECRUITING

Virginia Piper Cancer Institute Mercy Hospital-Unity Campus

Fridley, Minnesota, United States

RECRUITING

VPCI Oncology Research

Minneapolis, Minnesota, United States

RECRUITING

Methodist LeBonheur Healthcare

Memphis, Tennessee, United States

RECRUITING

Liver Center of Texas

Dallas, Texas, United States

RECRUITING

Methodist Hospital

Richardson, Texas, United States

RECRUITING

Outcomes

Primary Outcomes

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.

Time frame: 1 month

Secondary Outcomes

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.

Time frame: 1 Month

Ascertain Reference Range(s)

Ascertain reference range determination(s) for select CpG methylation sites

Time frame: 1 Month

Ascertain Sample Stability

Sample stability under various shipping conditions

Time frame: 1 Month

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

Overview

Conditions

Interventions

Eligibility

Locations (7)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts