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

Last updated: June 13, 2024
Sponsor: Helio Genomics
Overall Status: Active - Recruiting

Phase

N/A

Condition

Hepatitis C; Chronic

Diabetic Gastroparesis

Diabetic Foot Ulcers

Treatment

Multi-analyte Blood Test

Clinical Study ID

NCT05181826
001-2018
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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

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

Total Participants: 1200
Treatment Group(s): 1
Primary Treatment: Multi-analyte Blood Test
Phase:
Study Start date:
May 21, 2019
Estimated Completion Date:
December 31, 2025

Study 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.

Connect with a study center

  • Torrance Memorial Physician Network - Cancer Care

    Redondo Beach, California 90277
    United States

    Site Not Available

  • Allina Health, Virginia Piper Cancer Institute

    Coon Rapids, Minnesota 55433
    United States

    Active - Recruiting

  • Virginia Piper Cancer Institute Mercy Hospital-Unity Campus

    Fridley, Minnesota 55432
    United States

    Active - Recruiting

  • VPCI Oncology Research

    Minneapolis, Minnesota 55407
    United States

    Active - Recruiting

  • Methodist LeBonheur Healthcare

    Memphis, Tennessee 38104
    United States

    Active - Recruiting

  • Liver Center of Texas

    Dallas, Texas 75234
    United States

    Active - Recruiting

  • Methodist Hospital

    Richardson, Texas 75082
    United States

    Active - Recruiting

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