Skip to main content
OpenTrials
Recruiting

NCT Number: NCT05181826

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Cancer Blood-Borne Infections COPD Chronic Disease Chronic Hepatitis Communicable Diseases DNA Virus Infections Diabetes Diabetes Mellitus Digestive System Diseases Disease Attributes Endocrine System Diseases Fibrosis Flaviviridae Infections Glucose Metabolism Disorders Hepadnaviridae Infections Hepatitis Hepatitis B Hepatitis C Hepatitis, Chronic Hepatitis, Viral, Human Infections Liver Cirrhosis Liver Diseases Lung Diseases Lung Diseases, Obstructive Metabolic Diseases Neoplasms Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive RNA Virus Infections Respiratory Tract Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Loading trial locations.

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Multi-analyte Blood Test

Diagnostic Test

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

Primary outcomes

  1. Independent performance measure of sensitivity and specificity of a multi-analyte blood test

    Time frame: 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 outcomes

  1. To investigate potential endogenous and exogenous interfering substances of a multi-analyte blood test

    Time frame: 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.

  2. Ascertain Reference Range(s)

    Time frame: 1 Month

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

  3. Ascertain Sample Stability

    Time frame: 1 Month

    Sample stability under various shipping conditions

Study contacts

Contact information is provided by the study sponsor or research team.

Clinical Operations Manager

CONTACT

[email protected]

6263500537

Sponsors and collaborators

Lead sponsor

Helio Genomics

Industry

Registry information

Acronym: ELITE

Important dates

Study start
2019
Primary completion
2027
Study completion
2028
First posted
Jan 6, 2022
Registry last updated
Jul 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.