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

NCT05181826 | Unknown FDA Device

• 1 other identifier: 001-2018
• Study Type: observational
• Target: 1,200
• Locations: 1 country
• Sites: 7

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; Diabetes; COPD

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

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

  1 Month

• Ascertain Reference Range(s)

  1 Month

• Ascertain Sample Stability

  1 Month

Interventions

Multi-analyte Blood Test DIAGNOSTIC_TEST

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Healthy subjects, subjects diagnosed with active cancer, subjects in cancer remission, and subjects diagnosed with a benign disease will eligible to participate in this study.

You may qualify if:

• Age 18 years or older.
• 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. .

You may not qualify if:

• Patients that are unwilling or unable to sign the Informed Consent Form will be excluded.
• 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.

Sponsors & Collaborators

• Helio Genomics: lead

Study Sites (7)

Torrance Memorial Physician Network - Cancer Care

Redondo Beach, California, 90277, United States

ACTIVE NOT RECRUITING

Allina Health, Virginia Piper Cancer Institute

Coon Rapids, Minnesota, 55433, United States

RECRUITING

Virginia Piper Cancer Institute Mercy Hospital-Unity Campus

Fridley, Minnesota, 55432, United States

RECRUITING

VPCI Oncology Research

Minneapolis, Minnesota, 55407, United States

RECRUITING

Methodist LeBonheur Healthcare

Memphis, Tennessee, 38104, United States

RECRUITING

Liver Center of Texas

Dallas, Texas, 75234, United States

RECRUITING

Methodist Hospital

Richardson, Texas, 75082, United States

RECRUITING

MeSH Terms

Conditions

Neoplasms; Liver Cirrhosis; Hepatitis, Chronic; Hepatitis B; Hepatitis C; Diabetes Mellitus; Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Hepatitis; Chronic Disease; Disease Attributes; Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Flaviviridae Infections; RNA Virus Infections; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Taggert

  Helio Health

  STUDY DIRECTOR

Central Study Contacts

Clinical Operations Manager

CONTACT

6263500537; octavia@heliogenomics.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 17, 2021
• First Posted: January 6, 2022
• Study Start: May 21, 2019
• Primary Completion: September 1, 2025
• Study Completion: December 1, 2025
• Last Updated: June 14, 2024

Record last verified: 2023-07

Locations

US (7)