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Development and Validation of Harbinger Health Test for Early Cancer Detection (CORE-HH)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05435066
Recruitment Status : Recruiting
First Posted : June 28, 2022
Last Update Posted : December 4, 2023
Sponsor:
Information provided by (Responsible Party):
Harbinger Health

Study Description
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Brief Summary:
This is a prospective, multi-center, observational study with a collection of biospecimens and clinical data from approximately 10,000 participants from up to 40 clinical network sites and locations in the United States. The objective of this study is to collect blood samples, tissue samples, and associated clinical data from participants with a variety of solid tumor and hematologic cancers and non-cancer participants for testing and the development of a screening test for early cancer detection.

Condition or disease Intervention/treatment
Cancer Diagnostic Test: Harbinger Health Test

Study Design
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Study Type : Observational
Estimated Enrollment : 10000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Cancer ORigin Epigenetics-Harbinger Health - Collection of Blood and Tissue Samples From Cancer and Non-Cancer Subjects for Validation of a Novel Blood-Based Multi-Cancer Screening Test
Actual Study Start Date : June 21, 2022
Estimated Primary Completion Date : December 2023
Estimated Study Completion Date : July 3, 2025
Groups and Cohorts
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Group/Cohort Intervention/treatment
Arm 1 - cancer group
Arm 1 - newly diagnosed cancer subjects
 Diagnostic Test: Harbinger Health Test
This trial will be used to test the ability of the Harbinger Health test to detect cancer using blood-based biomarkers in a large cohort of patients with cancer and matched asymptomatic controls. The asymptomatic controls will be followed for up to 2 years
Arm 2 - non cancer group
Arm 2 - non-cancer subjects
 Diagnostic Test: Harbinger Health Test
This trial will be used to test the ability of the Harbinger Health test to detect cancer using blood-based biomarkers in a large cohort of patients with cancer and matched asymptomatic controls. The asymptomatic controls will be followed for up to 2 years


Outcome Measures
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Primary Outcome Measures :
  1. Detection of cancer or non-cancer using Harbinger Test [ Time Frame: upto 2 years ]
    Analyze Subject's cfDNA from blood samples for "cancer" or "non-cancer" signals using the Harbinger Health test, and compare results of the test to clinical diagnosis

  2. Performance for specific cancer types using Harbinger Test [ Time Frame: upto 2 years ]
    Sub-analysis by clinical diagnosis of cancer type (e.g. Breast cancer) to determine how well the Harbinger Health test detects specific tumor types

  3. Identify the correct tumor type by Harbinger Test [ Time Frame: upto 2 years ]
    Analyze Subject's cfDNA from blood samples to accurately identify specific tumor types (e.g. Breast cancer) using the Harbinger Health test, by comparing results of the test to clinical diagnosis


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 79 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Newly diagnosed cancer subjects and non-cancer subjects
Criteria

Inclusion Criteria:

  • Inclusion Criteria - Both arms

Subjects must meet the following criteria in order to be included in the research study:

  • Written or electronic informed consent
  • Subject is 20 - 79 years of age at the time of signature of the informed consent form (ICF)
  • Male or female subjects

Inclusion Criteria Arm 1 - Cancer Subjects

Arm 1 subjects enrolled in the study must meet the following inclusion criteria:

  1. - A confirmed diagnosis (within 180 days prior to enrollment) of a type of cancer from the study list of cancer types for enrollment, including the following types:

    • Stage I to Stage IV solid tumor cancer
    • Non-solid (hematologic) cancer or

  2. - A high suspicion of cancer by imaging (within 180 days prior to enrollment) of a type of cancer from the study list of cancer types for enrollment, including the following types:

    • Stage I to Stage IV solid tumor cancer

    • Non-solid (hematologic) cancer

      • For subjects to be enrolled with a confirmed cancer diagnosis, the subject's cancer diagnosis will be based upon assessment of a pathological specimen,
      • Subject's cancer is treatment-naïve

Inclusion Criteria Arm 2 - Non-Cancer Subjects (All Cohorts)

Arm 2 subjects enrolled in the study must meet the following inclusion criteria:

  • Subject's health permits participation and the subject is not suspected of having cancer based on provider assessment.
  • The subject was not diagnosed with cancer or received cancer treatment within the last 5 years (persons with completely resected ductal carcinoma in-situ or non-melanoma skin cancer are permitted).

Exclusion Criteria:

Subject self-reporting OR available medical records at the time of screening are acceptable for assessment of all exclusion criteria.

Exclusion Criteria - Both arms

Subjects who meet any of the following criteria will be excluded from study entry:

  • Subject is suffering from any febrile illness defined as a temperature >101.5°F within the last 48 hrs.
  • Subject is pregnant (by self-report of pregnancy status).

Exclusion Criteria Arm 1 - Cancer Subjects

Subjects who meet any of the following criteria will be excluded from study entry:

  • Subject has a known prior diagnosis of any other type of cancer (except completely resected ductal carcinoma in-situ or non-melanoma skin cancer) separate from the confirmed cancer diagnosis associated with study enrollment.

  • Subject is currently receiving, or has in the past received, any of the following definitive therapies to treat their current cancer:

    • Surgical treatment, surgical removal, or surgical management of the cancer beyond that required to establish the cancer diagnosis. Surgical or biopsy procedures that remove more tissue than required to establish the cancer diagnosis, or that were performed to manage symptoms or initiate cancer treatment prior to blood sample collection will be considered 'definitive' and are not permissible regardless of the residual tumor mass remaining in the subject.
    • Chemotherapy (local, regional, or systemic) including chemoembolization targeted therapy;
    • Immunotherapy including cancer vaccines;
    • Hormone therapy; or
    • Radiation therapy (a single dose of palliative radiation prior to study start is allowed).
  • The subject is a recipient of an organ transplant or prior non-autologous (allogeneic) bone marrow or stem cell transplant.

Exclusion Criteria Arm 2 - Non-cancer Subjects

Subjects who meet any of the following criteria will be excluded from study entry:

- The subject is the recipient of an organ transplant or prior non-autologous (allogeneic) bone marrow or stem cell transplant.

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): NCT05435066


Contacts
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Contact: Sarah Cannon Development Innovations, LLC 844-710-6157 SCRI.InnovationsMedical@scri.com

Locations
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Sponsors and Collaborators
Harbinger Health
Investigators
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Study Chair: Dax Kurbegov, MD Sarah Cannon Development Innovations
Study Director: Jeffrey Gregg, MD Harbinger Health
More Information
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Responsible Party: Harbinger Health
ClinicalTrials.gov Identifier: NCT05435066    
Other Study ID Numbers: HH-PRT-0001
Tissue 32 ( Other Identifier: SCDI )
First Posted: June 28, 2022    Key Record Dates
Last Update Posted: December 4, 2023
Last Verified: December 2023

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Harbinger Health:
cancer
early detection
blood-based cancer screening
cfDNA
cancer diagnosis