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

July 25, 2025 updated by: Harbinger Health

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

This is a prospective, multi-center, observational study with a collection of biospecimens and clinical data from approximately 10,000 participants from up to 125 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

8038

Contacts and Locations

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

Study Locations

  • United States
    • Alabama
      • Daphne, Alabama, United States, 36526
        • Southern Cancer Center
    • Alaska
      • Anchorage, Alaska, United States, 99508
        • Alaska Oncology and Hematology, LLC
      • Anchorage, Alaska, United States, 99508
        • Alaska Womens Cancer Care
    • Arizona
      • Prescott Valley, Arizona, United States, 86314
        • Arizona Oncology Associates HAL
    • California
      • Anaheim, California, United States, 33324
        • Pacific Cancer Medical Center
      • Fresno, California, United States, 93720
        • Central California ENT Medical Group
      • San Diego, California, United States, 92108
        • South Coast Gynecologic Oncology, INC
      • San Diego, California, United States, 92121
        • South Coast Gynecologic Oncology, INC
      • Santa Barbara, California, United States, 93105
        • Sansum Clinic
      • Torrance, California, United States, 90505
        • Gynecologic Oncology Associates
    • Colorado
      • Littleton, Colorado, United States, 80120
        • Colorado Primary Health Care
    • Delaware
      • Newark, Delaware, United States, 19713
        • Medical Oncology Hematology Consultants, PA
    • Florida
      • Altamonte Springs, Florida, United States, 32803
        • Central Florida Pulmonary Group - Altamonte Springs
      • Boca Raton, Florida, United States, 33487
        • South Florida Center for Gynecologic Oncology
      • Boca Raton, Florida, United States, 33434
        • ENT and Allergy Associates of Florida, LLC
      • Boca Raton, Florida, United States, 33486
        • Plastic Surgery Specialists of Boca Raton
      • Boca Raton, Florida, United States, 33487
        • ENT and Allergy Associates of Florida, LLC
      • Boynton Beach, Florida, United States, 33437
        • Urology Center of South Florida
      • Boynton Beach, Florida, United States, 33472
        • Advanced Cancer Surgery and Digestive Health
      • Brandon, Florida, United States, 33511
        • ENT and Allergy Associates of Florida, LLC
      • Coconut Creek, Florida, United States, 33073
        • Zoyla Almedia, MD PA
      • Fort Pierce, Florida, United States, 34950
        • ENT and Allergy Associates of Florida, LLC
      • Fort Pierce, Florida, United States, 34950
        • Stuart Oncology Associates
      • Kissimmee, Florida, United States, 34741
        • I.H.S. Health
      • Okeechobee, Florida, United States, 34972
        • ENT and Allergy Associates of Florida, LLC - Okeechobee
      • Orlando, Florida, United States, 30803
        • Central Florida Pulmonary Group
      • Orlando, Florida, United States, 32825
        • Central Florida Pulmonary Group - Dylan Loren Cir
      • Palm Bay, Florida, United States, 32901
        • Cancer Care Centers of Brevard
      • Palm Beach Gardens, Florida, United States, 33410
        • ENT and Allergy Associates of Florida, LLC
      • Pensacola, Florida, United States, 32503
        • Woodlands Medical Specialists
      • Plantation, Florida, United States, 33324
        • ENT and Allergy Associates of Florida, LLC
      • Port St. Lucie, Florida, United States, 34952
        • ENT and Allergy Associates of Florida, LLC
      • Port St. Lucie, Florida, United States, 34952
        • Stuart Oncology Associates
      • Port St. Lucie, Florida, United States, 34986
        • Stuart Oncology Associates
      • Stuart, Florida, United States, 34994
        • Stuart Oncology Associates
      • Wesley Chapel, Florida, United States, 33544
        • ENT and Allergy Associates of Florida, LLC
      • West Palm Beach, Florida, United States, 33401
        • ENT and Allergy Associates of Florida, LLC
    • Georgia
      • Johns Creek, Georgia, United States, 30097
        • Advanced Urology - John's Creek
      • Lawrenceville, Georgia, United States, 30045
        • Advanced Urology - Lawrenceville
      • Marietta, Georgia, United States, 30060
        • Advanced Urology - Marietta
      • Roswell, Georgia, United States, 30076
        • Advanced Urology - Rosewell
      • Snellville, Georgia, United States, 30078
        • Advanced Urology - Snellville
    • Illinois
      • Arlington Heights, Illinois, United States, 60005
        • Illinois Cancer Specialists
      • Hinsdale, Illinois, United States, 60521
        • Hope and Healing Cancer Services
      • Skokie, Illinois, United States, 60076
        • Hem/Onc of the North Shore
    • Indiana
      • Evansville, Indiana, United States, 47710
        • Evansville Surgical Associates-Mary Street
      • Evansville, Indiana, United States, 47714
        • Evansville Surgical Associates-Mary's Drive
      • Newburgh, Indiana, United States, 47630
        • Evansville Surgical Associates-Gateway Boulevard
    • Iowa
      • Des Moines, Iowa, United States, 50309
        • Mission Cancer and Blood
    • Kansas
      • Wichita, Kansas, United States, 67205
        • Wichita Urology Group - W. 21st Street
      • Wichita, Kansas, United States, 67206
        • Wichita Urology Group- P.A. - 2077 N. Webb Road
      • Wichita, Kansas, United States, 67214
        • Breast Care Specialists
      • Wichita, Kansas, United States, 67226
        • Kansas Surgery & Recovery Center
      • Wichita, Kansas, United States, 67226
        • Wichita Urology Group- 2626 Webb Road
    • Louisiana
      • Hammond, Louisiana, United States, 70403
        • Northlake Gastroenterology Associates
      • Hammond, Louisiana, United States, 70433
        • Northlake Gastroenterology Associates
    • Maryland
      • Columbia, Maryland, United States, 21044
        • Maryland Oncology Hematology
    • Michigan
      • Farmington Hills, Michigan, United States, 48334
        • Comprehensive Urology - Farmington Hills
      • Novi, Michigan, United States, 48375
        • Comprehensive Urology - Novi
      • Roseville, Michigan, United States, 48066
        • Michigan Cancer Specialists
      • Roseville, Michigan, United States, 48066
        • Comprehensive Urology - Roseville
      • Royal Oak, Michigan, United States, 48073
        • Comprehensive Urology - Royal Oak
      • Sterling Heights, Michigan, United States, 48314
        • Comprehensive Urology - Sterling Heights
    • Minnesota
      • Minneapolis, Minnesota, United States, 55404
        • Minnesota Oncology Hematology
    • Nebraska
      • Lincoln, Nebraska, United States, 68510
        • Somnos Clinical Research
    • Nevada
      • Las Vegas, Nevada, United States, 89103
        • Hope Cancer Care of Nevada
      • Reno, Nevada, United States, 89511
        • Cancer Care Specialists - Reno
    • New Jersey
      • Belleville, New Jersey, United States, 07109
        • New Jersey Cancer Care
      • Brick, New Jersey, United States, 08724
        • New Jersey Hematology Oncology Associates
      • Jersey City, New Jersey, United States, 07306
        • Surgical Specialists of New York - Jersey City
      • Mountain Lakes, New Jersey, United States, 07046
        • Oncology Hematology Specialists
      • Paramus, New Jersey, United States, 07652
        • Center of Dermatology and Skin Surgery, LLC
    • New York
      • Albany, New York, United States, 12208
        • Women's Cancer Care Associates LLC
      • Astoria, New York, United States, 11102
        • Surgical Specialists of NY - Astoria
      • Bronx, New York, United States, 10469
        • Hirschfeld Oncology
      • Brooklyn, New York, United States, 11201
        • New York Gastroenterology Associates - Pierrepont
      • Brooklyn, New York, United States, 11234
        • Gardith Joseph Medical P.C. Quality Cancer Care
      • Brooklyn, New York, United States, 11234
        • Vantage Medical Associates
      • Camillus, New York, United States, 13031
        • Associated Gastroenterologists of Central New York - Camillus
      • East Syracuse, New York, United States, 13057
        • Associated Gastroenterologists of Central New York - Syracuse
      • Far Rockaway, New York, United States, 11691
        • Vantage Medical Associates
      • Fayetteville, New York, United States, 13066
        • Associated Gastroenterologists of Central New York - Fayetteville
      • Fishkill, New York, United States, 12524
        • Hudson Valley Cancer Center - Fishkill
      • Lake Success, New York, United States, 11042
        • Advanced Urology Centers of NY
      • Liverpool, New York, United States, 13088
        • Gastroenterology Oncology Associates
      • New York, New York, United States, 10024
        • New York Gastroenterology Associates - Columbus Ave
      • New York, New York, United States, 10028
        • New York Gastroenterology Associates - 86th Street
      • New York, New York, United States, 10075
        • New York Gastroenterology Associates - E 79th St
      • New York, New York, United States, 10128
        • New York Gastroenterology Associates - 5th Ave
      • New York City, New York, United States, 10128
        • Surgical Specialists of NY - New York City
      • Nyack, New York, United States, 10960
        • Hematology Oncology Associates of Rockland
      • Nyack, New York, United States, 10960
        • Advanced Radiation Oncology Services
      • Poughkeepsie, New York, United States, 12603
        • Premier Medical Group of the Hudson Valley
      • Poughkeepsie, New York, United States, 12601
        • Hudson Valley Cancer Center - Poughkeepsie
      • Woodmere, New York, United States, 11598
        • Westmed Medical Group
      • Yorktown Heights, New York, United States, 10598
        • Hudson Valley Cancer Center - Yorktown Heights
    • Ohio
      • Dayton, Ohio, United States, 45414
        • Dayton Physicians Network
    • Oregon
      • Eugene, Oregon, United States, 97401
        • Oncology Associates of Oregon
      • Portland, Oregon, United States, 97213
        • Northwest Cancer Specialists-
    • Pennsylvania
      • Allentown, Pennsylvania, United States, 18104
        • Eastern Pennsylvania Gastroenterology & Liver Specialists, LLC
      • Altoona, Pennsylvania, United States, 16648
        • Blair Gastroenterology Associates
      • Broomall, Pennsylvania, United States, 19008
        • Consultants in Medical Oncology & Hematology
      • Wynnewood, Pennsylvania, United States, 19096
        • Pulmonology Associates Inc.
      • Wynnewood, Pennsylvania, United States, 19096
        • Pulmonology Associates INC
      • York, Pennsylvania, United States, 17403
        • Cancer Care Associates of York
    • Tennessee
      • Knoxville, Tennessee, United States, 37909
        • GIA Clinical Trials, LLC
      • Nashville, Tennessee, United States, 37208
        • Meharry Medical College
      • Nashville, Tennessee, United States, 37209
        • Urology Associates
      • Nashville, Tennessee, United States, 37203
        • Advantage Clinical Research
      • Nashville, Tennessee, United States, 37203
        • HCA Research Institute
    • Texas
      • Amarillo, Texas, United States, 79106
        • Texas Oncology - West Texas
      • Beaumont, Texas, United States, 77702
        • Texas Oncology - Gulf Coast
      • Dallas, Texas, United States, 75246
        • Texas Oncology-Baylor Charles A. Sammons Cancer Center
      • Dallas, Texas, United States, 75231
        • Texas Oncology - Presbyterian Cancer Center Dallas
      • Dallas, Texas, United States, 75230
        • Texas Oncology - Dallas
      • Fort Worth, Texas, United States, 76104
        • Texas Oncology-Fort Worth
      • Houston, Texas, United States, 77074
        • Houston Digestive Diseases Consultants
      • McAllen, Texas, United States, 78503
        • Texas Oncology - McAllen
      • McKinney, Texas, United States, 75071
        • Texas Oncology - Northeast Texas Cancer and Research
      • Plano, Texas, United States, 75093
        • Texas Oncology - Plano West
      • Plano, Texas, United States, 75075
        • Texas Oncology - Plano East
      • San Antonio, Texas, United States, 78240
        • Texas Oncology - San Antonio
      • Shenandoah, Texas, United States, 77384
        • Center for Digestive Disease
      • Tyler, Texas, United States, 75702
        • Texas Oncology - Northeast Texas Cancer and Research
    • Virginia
      • Fairfax, Virginia, United States, 22031
        • Virginia Cancer Specialists
      • Norfolk, Virginia, United States, 23502
        • Virginia Oncology Associates
      • Winchester, Virginia, United States, 22601
        • Shenandoah Oncology
    • Washington
      • Tacoma, Washington, United States, 98405
        • Northwest Medical Specialties, PLLC

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

20 years to 79 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Newly diagnosed cancer subjects and non-cancer subjects

Description

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.

  • A confirmed diagnosis or high suspicion of cancer (stage I to IV solid cancer or hematologic cancer) by imaging within 180 days prior to enrollment; not to include myelodysplastic and myeloproliferative syndromes
  • Subject's cancer diagnosis is based upon assessment of a pathological specimen or high suspicion of cancer by imaging
  • 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).

Part 1B Only :

- Subject has no known current cancer and has 1 of the follow conditions:

o An Advanced Adenoma (AA) of the gastrointestinal tract as defined as an adenoma that is ≤10mm in size Subjects with any one of the criteria would be eligible High grade displasia or ≥10 adenoma: any size Tubulovillous adenoma, any size Tubular adenoma ≥10mm Traditional serrated adenoma ≥10mm

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 with a prior history of cancer within 5 years will not be allowed to participate in the study
  • More than 1 active cancer diagnosis (ie. a subject presenting with recurrent breast cancer and newly diagnosed lung cancer would be excluded; subject with prior (>5 years ago) treated breast cancer without recurrence and presenting with newly diagnosed lung cancer would be eligible).

  • 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.
  • Subject who has undergone a bowel preparation for a gastrointestinal malignancy within 3 days of an anticipated blood draw.

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.

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: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

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 non-cancer controls. The non-cancer controls will be followed for up to 1 year
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 non-cancer controls. The non-cancer controls will be followed for up to 1 year

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Detection of cancer or non-cancer using Harbinger Test
Time Frame: Up to 12 months
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
Up to 12 months
Performance for specific cancer types using Harbinger Test
Time Frame: Up to 12 months
Sub-analysis by clinical diagnosis of cancer type (e.g. Breast cancer) to determine how well the Harbinger Health test detects specific tumor types
Up to 12 months
Identify the correct tumor type by Harbinger Test
Time Frame: Up to 12 months
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
Up to 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluate performance of the Harbinger Health Test by tumor stage
Time Frame: Up to 12 months
Assess Harbinger Health test performance with repeat of primary subgroup analysis through Tumor Stage within Cancer Type.
Up to 12 months
Evaluate performance of the Harbinger Health Test to discriminate hyperplasia Advanced Adenoma.
Time Frame: Up to 12 months
Assess Harbinger Health test performance by repeat of Primary with Subgroup Analysis of Non-Cancer vs. Hyperplasia (Advanced Adenoma).
Up to 12 months

Collaborators and Investigators

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

Sponsor

Harbinger Health

Investigators

  • Study Director: Hutan Ashrafian, MD MBA PhD, Harbinger Health
  • Study Chair: Luke Pike, MD DPhil, Memorial Sloan Kettering Cancer Center
  • Study Chair: Dax Kurbegov, MD, Sarah Cannon

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)

June 21, 2022

Primary Completion (Actual)

June 11, 2025

Study Completion (Actual)

June 11, 2025

Study Registration Dates

First Submitted

June 14, 2022

First Submitted That Met QC Criteria

June 27, 2022

First Posted (Actual)

June 28, 2022

Study Record Updates

Last Update Posted (Actual)

July 29, 2025

Last Update Submitted That Met QC Criteria

July 25, 2025

Last Verified

July 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • HH-PRT-0001
  • Tissue 32 (Other Identifier: SCDI)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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