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

NCT ID: NCT05181826

Last Updated: 2024-06-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

1200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-05-21

Study Completion Date

2025-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Cancer Liver Cirrhosis Chronic Hepatitis Hepatitis B Hepatitis C Diabetes COPD

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Interventions

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Multi-analyte Blood Test

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Helio Genomics

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Taggert

Role: STUDY_DIRECTOR

Helio Health

Locations

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Torrance Memorial Physician Network - Cancer Care

Redondo Beach, California, United States

Site Status ACTIVE_NOT_RECRUITING

Allina Health, Virginia Piper Cancer Institute

Coon Rapids, Minnesota, United States

Site Status RECRUITING

Virginia Piper Cancer Institute Mercy Hospital-Unity Campus

Fridley, Minnesota, United States

Site Status RECRUITING

VPCI Oncology Research

Minneapolis, Minnesota, United States

Site Status RECRUITING

Methodist LeBonheur Healthcare

Memphis, Tennessee, United States

Site Status RECRUITING

Liver Center of Texas

Dallas, Texas, United States

Site Status RECRUITING

Methodist Hospital

Richardson, Texas, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Clinical Operations Manager

Role: CONTACT

6263500537

Facility Contacts

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Kathryn Gruetzman

Role: primary

763-236-0814

Lynne Schroeder

Role: primary

Kelsey Froemming

Role: primary

Carol Jones

Role: primary

901-516-8078

Ariela Moreno

Role: primary

Araceli Torres

Role: primary

Other Identifiers

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001-2018

Identifier Type: -

Identifier Source: org_study_id

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