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CancerCORE-HHNCT05435066

Development and Validation of Harbinger Health Test for Early Cancer Detection

An observational study of Cancer, run by Harbinger Health at 128 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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 125 clinical network sites and locations in the United States. Read more about this study

Who is it for?
Ages 20 to 79 yearsHealthy volunteers can take part
Conditions the study is for
Cancer
What is being tested?
Harbinger Health Test
How many people
8,038 participants
Where
128 sitesUnited States
Study dates
21 Jun 2022to 11 Jun 2025
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 79 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: Newly diagnosed cancer subjects and non-cancer subjects

Who may be able to join

  • 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
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  • 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

Who cannot join

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

Trial locations and contacts

128 sites in 1 country.

128 sites in 1 country

United States128 sites

  • Women's Cancer Care Associates LLC

    Albany, New York, 12208

  • Eastern Pennsylvania Gastroenterology & Liver Specialists, LLC

    Allentown, Pennsylvania, 18104

  • Central Florida Pulmonary Group - Altamonte Springs

    Altamonte Springs, Florida, 32803

  • Blair Gastroenterology Associates

    Altoona, Pennsylvania, 16648

  • Texas Oncology - West Texas

    Amarillo, Texas, 79106

  • Pacific Cancer Medical Center

    Anaheim, California, 33324

  • Alaska Oncology and Hematology, LLC

    Anchorage, Alaska, 99508

  • Alaska Womens Cancer Care

    Anchorage, Alaska, 99508

  • Illinois Cancer Specialists

    Arlington Heights, Illinois, 60005

  • Surgical Specialists of NY - Astoria

    Astoria, New York, 11102

  • Texas Oncology - Gulf Coast

    Beaumont, Texas, 77702

  • New Jersey Cancer Care

    Belleville, New Jersey, 07109

  • ENT and Allergy Associates of Florida, LLC

    Boca Raton, Florida, 33434

  • Plastic Surgery Specialists of Boca Raton

    Boca Raton, Florida, 33486

  • ENT and Allergy Associates of Florida, LLC

    Boca Raton, Florida, 33487

  • South Florida Center for Gynecologic Oncology

    Boca Raton, Florida, 33487

  • Urology Center of South Florida

    Boynton Beach, Florida, 33437

  • Advanced Cancer Surgery and Digestive Health

    Boynton Beach, Florida, 33472

  • ENT and Allergy Associates of Florida, LLC

    Brandon, Florida, 33511

  • New Jersey Hematology Oncology Associates

    Brick, New Jersey, 08724

  • New York Gastroenterology Associates - Pierrepont

    Brooklyn, New York, 11201

  • Gardith Joseph Medical P.C. Quality Cancer Care

    Brooklyn, New York, 11234

  • Vantage Medical Associates

    Brooklyn, New York, 11234

  • Consultants in Medical Oncology & Hematology

    Broomall, Pennsylvania, 19008

  • Associated Gastroenterologists of Central New York - Camillus

    Camillus, New York, 13031

  • Zoyla Almedia, MD PA

    Coconut Creek, Florida, 33073

  • Maryland Oncology Hematology

    Columbia, Maryland, 21044

  • Texas Oncology - Dallas

    Dallas, Texas, 75230

  • Texas Oncology - Presbyterian Cancer Center Dallas

    Dallas, Texas, 75231

  • Texas Oncology-Baylor Charles A. Sammons Cancer Center

    Dallas, Texas, 75246

  • Southern Cancer Center

    Daphne, Alabama, 36526

  • Dayton Physicians Network

    Dayton, Ohio, 45414

  • Mission Cancer and Blood

    Des Moines, Iowa, 50309

  • Associated Gastroenterologists of Central New York - Syracuse

    East Syracuse, New York, 13057

  • Oncology Associates of Oregon

    Eugene, Oregon, 97401

  • Evansville Surgical Associates-Mary Street

    Evansville, Indiana, 47710

  • Evansville Surgical Associates-Mary's Drive

    Evansville, Indiana, 47714

  • Virginia Cancer Specialists

    Fairfax, Virginia, 22031

  • Vantage Medical Associates

    Far Rockaway, New York, 11691

  • Comprehensive Urology - Farmington Hills

    Farmington Hills, Michigan, 48334

  • Associated Gastroenterologists of Central New York - Fayetteville

    Fayetteville, New York, 13066

  • Hudson Valley Cancer Center - Fishkill

    Fishkill, New York, 12524

  • Texas Oncology-Fort Worth

    Fort Worth, Texas, 76104

  • Central California ENT Medical Group

    Fresno, California, 93720

  • ENT and Allergy Associates of Florida, LLC

    Ft. Pierce, Florida, 34950

  • Stuart Oncology Associates

    Ft. Pierce, Florida, 34950

  • Northlake Gastroenterology Associates

    Hammond, Louisiana, 70403

  • Northlake Gastroenterology Associates

    Hammond, Louisiana, 70433

  • Hope and Healing Cancer Services

    Hinsdale, Illinois, 60521

  • Houston Digestive Diseases Consultants

    Houston, Texas, 77074

  • Surgical Specialists of New York - Jersey City

    Jersey City, New Jersey, 07306

  • Advanced Urology - John's Creek

    Johns Creek, Georgia, 30097

  • I.H.S. Health

    Kissimmee, Florida, 34741

  • GIA Clinical Trials, LLC

    Knoxville, Tennessee, 37909

  • Advanced Urology Centers of NY

    Lake Success, New York, 11042

  • Hope Cancer Care of Nevada

    Las Vegas, Nevada, 89103

  • Advanced Urology - Lawrenceville

    Lawrenceville, Georgia, 30045

  • Somnos Clinical Research

    Lincoln, Nebraska, 68510

  • Colorado Primary Health Care

    Littleton, Colorado, 80120

  • Gastroenterology Oncology Associates

    Liverpool, New York, 13088

  • Advanced Urology - Marietta

    Marietta, Georgia, 30060

  • Texas Oncology - McAllen

    McAllen, Texas, 78503

  • Texas Oncology - Northeast Texas Cancer and Research

    McKinney, Texas, 75071

  • Minnesota Oncology Hematology

    Minneapolis, Minnesota, 55404

  • Oncology Hematology Specialists

    Mountain Lakes, New Jersey, 07046

  • Advantage Clinical Research

    Nashville, Tennessee, 37203

  • HCA research Institute

    Nashville, Tennessee, 37203

  • Meharry Medical College

    Nashville, Tennessee, 37208

  • Urology Associates

    Nashville, Tennessee, 37209

  • New York Gastroenterology Associates - Columbus Ave

    New York, New York, 10024

  • New York Gastroenterology Associates - 86th Street

    New York, New York, 10028

  • New York Gastroenterology Associates - E 79th St

    New York, New York, 10075

  • New York Gastroenterology Associates - 5th Ave

    New York, New York, 10128

  • Surgical Specialists of NY - New York City

    New York, New York, 10128

  • Medical Oncology Hematology Consultants, PA

    Newark, Delaware, 19713

  • Evansville Surgical Associates-Gateway Boulevard

    Newburgh, Indiana, 47630

  • Virginia Oncology Associates

    Norfolk, Virginia, 23502

  • Comprehensive Urology - Novi

    Novi, Michigan, 48375

  • Advanced Radiation Oncology Services

    Nyack, New York, 10960

  • Hematology Oncology Associates of Rockland

    Nyack, New York, 10960

  • ENT and Allergy Associates of Florida, LLC - Okeechobee

    Okeechobee, Florida, 34972

  • Central Florida Pulmonary Group

    Orlando, Florida, 30803

  • Central Florida Pulmonary Group - Dylan Loren Cir

    Orlando, Florida, 32825

  • Cancer Care Centers of Brevard

    Palm Bay, Florida, 32901

  • ENT and Allergy Associates of Florida, LLC

    Palm Beach Gardens, Florida, 33410

  • Center of Dermatology and Skin Surgery, LLC

    Paramus, New Jersey, 07652

  • Woodlands Medical Specialists

    Pensacola, Florida, 32503

  • Texas Oncology - Plano East

    Plano, Texas, 75075

  • Texas Oncology - Plano West

    Plano, Texas, 75093

  • ENT and Allergy Associates of Florida, LLC

    Plantation, Florida, 33324

  • ENT and Allergy Associates of Florida, LLC

    Port Saint Lucie, Florida, 34952

  • Stuart Oncology Associates

    Port Saint Lucie, Florida, 34952

  • Stuart Oncology Associates

    Port Saint Lucie, Florida, 34986

  • Northwest Cancer Specialists-

    Portland, Oregon, 97213

  • Hudson Valley Cancer Center - Poughkeepsie

    Poughkeepsie, New York, 12601

  • Premier Medical Group of the Hudson Valley

    Poughkeepsie, New York, 12603

  • Arizona Oncology Associates HAL

    Prescott Valley, Arizona, 86314

  • Cancer Care Specialists - Reno

    Reno, Nevada, 89511

  • Comprehensive Urology - Roseville

    Roseville, Michigan, 48066

  • Michigan Cancer Specialists

    Roseville, Michigan, 48066

  • Advanced Urology - Rosewell

    Roswell, Georgia, 30076

  • Comprehensive Urology - Royal Oak

    Royal Oak, Michigan, 48073

  • Texas Oncology - San Antonio

    San Antonio, Texas, 78240

  • South Coast Gynecologic Oncology, Inc

    San Diego, California, 92108

  • South Coast Gynecologic Oncology, INC

    San Diego, California, 92121

  • Sansum Clinic

    Santa Barbara, California, 93105

  • Center for Digestive Disease

    Shenandoah, Texas, 77384

  • Hem/Onc of the North Shore

    Skokie, Illinois, 60076

  • Advanced Urology - Snellville

    Snellville, Georgia, 30078

  • Comprehensive Urology - Sterling Heights

    Sterling Heights, Michigan, 48314

  • Stuart Oncology Associates

    Stuart, Florida, 34994

  • Northwest Medical Specialties, PLLC

    Tacoma, Washington, 98405

  • Hirschfeld Oncology

    The Bronx, New York, 10469

  • Gynecologic Oncology Associates

    Torrance, California, 90505

  • Texas Oncology - Northeast Texas Cancer and Research

    Tyler, Texas, 75702

  • ENT and Allergy Associates of Florida, LLC

    Wesley Chapel, Florida, 33544

  • ENT and Allergy Associates of Florida, LLC

    West Palm Beach, Florida, 33401

  • Wichita Urology Group - W. 21st Street

    Wichita, Kansas, 67205

  • Wichita Urology Group- P.A. - 2077 N. Webb Road

    Wichita, Kansas, 67206

  • Breast Care Specialists

    Wichita, Kansas, 67214

  • Kansas Surgery & Recovery Center

    Wichita, Kansas, 67226

  • Wichita Urology Group- 2626 Webb Road

    Wichita, Kansas, 67226

  • Shenandoah Oncology

    Winchester, Virginia, 22601

  • Westmed Medical Group

    Woodmere, New York, 11598

  • Pulmonology Associates INC.

    Wynnewood, Pennsylvania, 19096

  • Pulmonology Associates INC

    Wynnewood, Pennsylvania, 19096

  • Cancer Care Associates of York

    York, Pennsylvania, 17403

  • Hudson Valley Cancer Center - Yorktown Heights

    Yorktown Heights, New York, 10598

Other trials in United States

About this study

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

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.

Conditions
Cancer
Being tested
Harbinger Health Test
Keywords
cancer, early detection, blood-based cancer screening, cfDNA, cancer diagnosis
Medical subject headings
Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Harbinger Health TestDiagnostic 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

Study groups in NCT05435066
Study groupRoleWhat they receive
Arm 1 - cancer groupArm 1 - newly diagnosed cancer subjects
Receives: Diagnostic Test: Harbinger Health Test
Arm 2 - non cancer groupArm 2 - non-cancer subjects
Receives: Diagnostic Test: Harbinger Health Test

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Detection of cancer or non-cancer using Harbinger Test

    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

    Measured: Up to 12 months

  2. Performance for specific cancer types using Harbinger Test

    Sub-analysis by clinical diagnosis of cancer type (e.g. Breast cancer) to determine how well the Harbinger Health test detects specific tumor types

    Measured: Up to 12 months

  3. Identify the correct tumor type by Harbinger Test

    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

    Measured: Up to 12 months

Secondary outcomes (2)

  1. Evaluate performance of the Harbinger Health Test by tumor stage

    Assess Harbinger Health test performance with repeat of primary subgroup analysis through Tumor Stage within Cancer Type.

    Measured: Up to 12 months

  2. Evaluate performance of the Harbinger Health Test to discriminate hyperplasia Advanced Adenoma.

    Assess Harbinger Health test performance by repeat of Primary with Subgroup Analysis of Non-Cancer vs. Hyperplasia (Advanced Adenoma).

    Measured: Up to 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Jun 2022
  2. Study start21 Jun 2022
  3. Primary completion11 Jun 2025
  4. Study completion11 Jun 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
8,038 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05435066
Sponsor's protocol ID
HH-PRT-0001
Other IDs
Tissue 32
Acronym
CORE-HH
Status last verified
Jul 2025
First submitted
14 Jun 2022
Last updated
29 Jul 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Cancer, run by Harbinger Health at 128 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 128 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Detection of cancer or non-cancer using Harbinger Test (time frame: Up to 12 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05435066.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2025.

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