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

Purpose

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

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  1. 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

  1. 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

Phase
Study Type
Observational
Observational Model
Other
Time Perspective
Prospective

Recruiting Locations

Allina Health, Virginia Piper Cancer Institute
Coon Rapids, Minnesota 55433
Contact:
Kathryn Gruetzman
763-236-0814
kathryn.gruetzman@allina.com

Virginia Piper Cancer Institute Mercy Hospital-Unity Campus
Fridley, Minnesota 55432
Contact:
Lynne Schroeder
lynne.schroeder@allina.com

VPCI Oncology Research
Minneapolis, Minnesota 55407
Contact:
Kelsey Froemming
kelsey.froemming@allina.com

Methodist LeBonheur Healthcare
Memphis, Tennessee 38104
Contact:
Carol Jones
901-516-8078
carol.jones@mlh.org

Liver Center of Texas
Dallas, Texas 75234
Contact:
Ariela Moreno
ariela@livercenteroftexas.com

Methodist Hospital
Richardson, Texas 75082
Contact:
Araceli Torres
aracelitorres@mhd.com

More Details

NCT ID
NCT05181826
Status
Recruiting
Sponsor
Helio Genomics

Study Contact

Clinical Operations Manager
6263500537
octavia@heliogenomics.com

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.