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

July 10, 2023 updated by: Helio Genomics
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

1200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • California
      • Redondo Beach, California, United States, 90277
        • Active, not recruiting
        • Torrance Memorial Physician Network - Cancer Care
    • Minnesota
      • Coon Rapids, Minnesota, United States, 55433
        • Recruiting
        • Allina Health, Virginia Piper Cancer Institute
        • Contact:
        • Principal Investigator:
          • Micheala Tsai, MD
      • Fridley, Minnesota, United States, 55432
        • Recruiting
        • Virginia Piper Cancer Institute Mercy Hospital-Unity Campus
        • Contact:
        • Principal Investigator:
          • Micheala Tsai
      • Minneapolis, Minnesota, United States, 55407
        • Recruiting
        • VPCI Oncology Research
        • Principal Investigator:
          • Micheala Tsai, MD
        • Contact:
    • Tennessee
      • Memphis, Tennessee, United States, 38104
        • Recruiting
        • Methodist LeBonheur Healthcare
        • Contact:
        • Principal Investigator:
          • Jiten Kothadia, MD
    • Texas
      • Dallas, Texas, United States, 75234
      • Richardson, Texas, United States, 75082
        • Recruiting
        • Methodist Hospital
        • Contact:
        • Principal Investigator:
          • Rohan Jeyarajah, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 Month
Ascertain Reference Range(s)
Time Frame: 1 Month
Ascertain reference range determination(s) for select CpG methylation sites
1 Month
Ascertain Sample Stability
Time Frame: 1 Month
Sample stability under various shipping conditions
1 Month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Helio Genomics

Investigators

  • Study Director: Taggert, Helio Health

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 21, 2019

Primary Completion (Estimated)

September 1, 2023

Study Completion (Estimated)

December 1, 2023

Study Registration Dates

First Submitted

December 17, 2021

First Submitted That Met QC Criteria

January 5, 2022

First Posted (Actual)

January 6, 2022

Study Record Updates

Last Update Posted (Actual)

July 11, 2023

Last Update Submitted That Met QC Criteria

July 10, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 001-2018

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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