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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

Tracking Information
First Submitted Date June 14, 2022
First Posted Date June 28, 2022
Last Update Posted Date December 4, 2023
Actual Study Start Date June 21, 2022
Estimated Primary Completion Date December 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 27, 2022)
  • 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
  • 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
  • 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
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Development and Validation of Harbinger Health Test for Early Cancer Detection
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
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Newly diagnosed cancer subjects and non-cancer subjects
Condition Cancer
Intervention 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
Study Groups/Cohorts
  • Arm 1 - cancer group
    Arm 1 - newly diagnosed cancer subjects
    Intervention: Diagnostic Test: Harbinger Health Test
  • Arm 2 - non cancer group
    Arm 2 - non-cancer subjects
    Intervention: Diagnostic Test: Harbinger Health Test
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: June 27, 2022)
10000
Original Estimated Enrollment Same as current
Estimated Study Completion Date July 3, 2025
Estimated Primary Completion Date December 2023   (Final data collection date for primary outcome measure)
Eligibility 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.

Sex/Gender
Sexes Eligible for Study: All
Ages 20 Years to 79 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts
Contact: Sarah Cannon Development Innovations, LLC 844-710-6157 SCRI.InnovationsMedical@scri.com
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT05435066
Other Study ID Numbers HH-PRT-0001
Tissue 32 ( Other Identifier: SCDI )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Current Responsible Party Harbinger Health
Original Responsible Party Same as current
Current Study Sponsor Harbinger Health
Original Study Sponsor Same as current
Collaborators Not Provided
Investigators
Study Chair: Dax Kurbegov, MD Sarah Cannon Development Innovations
Study Director: Jeffrey Gregg, MD Harbinger Health
PRS Account Harbinger Health
Verification Date December 2023