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

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ClinicalTrials.gov Identifier: NCT05181826
Recruitment Status : Recruiting
First Posted : January 6, 2022
Last Update Posted : July 11, 2023
Sponsor:
Information provided by (Responsible Party):
Helio Genomics

Study Description
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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.

Condition or disease Intervention/treatment
Cancer Liver Cirrhosis Chronic Hepatitis Hepatitis B Hepatitis C Diabetes COPD Diagnostic Test: Multi-analyte Blood Test

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 Design
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Study Type : Observational
Estimated Enrollment : 1200 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Collection of Blood From Healthy Patients, Patients With Benign Disease and Patients With Cancer
Actual Study Start Date : May 21, 2019
Estimated Primary Completion Date : September 2023
Estimated Study Completion Date : December 2023

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Intervention Details:
  • Diagnostic Test: Multi-analyte Blood Test
    Intend for the qualitative detection of DNA methylation markers for the detection of various types of cancer

Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.
Criteria

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.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05181826


Contacts
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Contact: Clinical Operations Manager 6263500537 octavia@heliogenomics.com

Locations
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United States, California
Torrance Memorial Physician Network - Cancer Care Active, not recruiting
Redondo Beach, California, United States, 90277
United States, Minnesota
Allina Health, Virginia Piper Cancer Institute Recruiting
Coon Rapids, Minnesota, United States, 55433
Contact: Kathryn Gruetzman    763-236-0814    kathryn.gruetzman@allina.com   
Principal Investigator: Micheala Tsai, MD         
Virginia Piper Cancer Institute Mercy Hospital-Unity Campus Recruiting
Fridley, Minnesota, United States, 55432
Contact: Lynne Schroeder       lynne.schroeder@allina.com   
Principal Investigator: Micheala Tsai         
VPCI Oncology Research Recruiting
Minneapolis, Minnesota, United States, 55407
Contact: Kelsey Froemming       kelsey.froemming@allina.com   
Principal Investigator: Micheala Tsai, MD         
United States, Tennessee
Methodist LeBonheur Healthcare Recruiting
Memphis, Tennessee, United States, 38104
Contact: Carol Jones    901-516-8078    carol.jones@mlh.org   
Principal Investigator: Jiten Kothadia, MD         
United States, Texas
Liver Center of Texas Recruiting
Dallas, Texas, United States, 75234
Contact: Ariela Moreno       ariela@livercenteroftexas.com   
Principal Investigator: Abdullah Mubarak, MD         
Methodist Hospital Recruiting
Richardson, Texas, United States, 75082
Contact: Araceli Torres       aracelitorres@mhd.com   
Principal Investigator: Rohan Jeyarajah, MD         
Sponsors and Collaborators
Helio Genomics
Investigators
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Study Director: Taggert Helio Health
More Information
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Responsible Party: Helio Genomics
ClinicalTrials.gov Identifier: NCT05181826    
Other Study ID Numbers: 001-2018
First Posted: January 6, 2022    Key Record Dates
Last Update Posted: July 11, 2023
Last Verified: July 2023

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Additional relevant MeSH terms:
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DNA Virus Infections
Hepatitis A
Hepatitis C
Hepatitis B
Hepatitis
Liver Cirrhosis
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
 Infections
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Blood-Borne Infections
Communicable Diseases
Flaviviridae Infections
Hepadnaviridae Infections
Pathologic Processes
Fibrosis