Development and Validation of Harbinger Health Test for Early Cancer Detection
CORE-HH
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
2 other identifiers
observational
8,038
1 country
128
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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2022
Typical duration for all trials
128 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 14, 2022
CompletedStudy Start
First participant enrolled
June 21, 2022
CompletedFirst Posted
Study publicly available on registry
June 28, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 11, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
June 11, 2025
CompletedJuly 29, 2025
July 1, 2025
3 years
June 14, 2022
July 25, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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
Up to 12 months
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
Up to 12 months
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
Up to 12 months
Secondary Outcomes (2)
Evaluate performance of the Harbinger Health Test by tumor stage
Up to 12 months
Evaluate performance of the Harbinger Health Test to discriminate hyperplasia Advanced Adenoma.
Up to 12 months
Study Arms (2)
Arm 1 - cancer group
Arm 1 - newly diagnosed cancer subjects
Arm 2 - non cancer group
Arm 2 - non-cancer subjects
Interventions
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
Eligibility Criteria
Newly diagnosed cancer subjects and non-cancer subjects
You may qualify if:
- 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
- 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-naĂ¯ve
- 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
You may not qualify if:
- 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
- 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:
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Harbinger Healthlead
Study Sites (128)
Southern Cancer Center
Daphne, Alabama, 36526, United States
Alaska Oncology and Hematology, LLC
Anchorage, Alaska, 99508, United States
Alaska Womens Cancer Care
Anchorage, Alaska, 99508, United States
Arizona Oncology Associates HAL
Prescott Valley, Arizona, 86314, United States
Pacific Cancer Medical Center
Anaheim, California, 33324, United States
Central California ENT Medical Group
Fresno, California, 93720, United States
South Coast Gynecologic Oncology, Inc
San Diego, California, 92108, United States
South Coast Gynecologic Oncology, INC
San Diego, California, 92121, United States
Sansum Clinic
Santa Barbara, California, 93105, United States
Gynecologic Oncology Associates
Torrance, California, 90505, United States
Colorado Primary Health Care
Littleton, Colorado, 80120, United States
Medical Oncology Hematology Consultants, PA
Newark, Delaware, 19713, United States
Central Florida Pulmonary Group - Altamonte Springs
Altamonte Springs, Florida, 32803, United States
ENT and Allergy Associates of Florida, LLC
Boca Raton, Florida, 33434, United States
Plastic Surgery Specialists of Boca Raton
Boca Raton, Florida, 33486, United States
ENT and Allergy Associates of Florida, LLC
Boca Raton, Florida, 33487, United States
South Florida Center for Gynecologic Oncology
Boca Raton, Florida, 33487, United States
Urology Center of South Florida
Boynton Beach, Florida, 33437, United States
Advanced Cancer Surgery and Digestive Health
Boynton Beach, Florida, 33472, United States
ENT and Allergy Associates of Florida, LLC
Brandon, Florida, 33511, United States
Zoyla Almedia, MD PA
Coconut Creek, Florida, 33073, United States
ENT and Allergy Associates of Florida, LLC
Ft. Pierce, Florida, 34950, United States
Stuart Oncology Associates
Ft. Pierce, Florida, 34950, United States
I.H.S. Health
Kissimmee, Florida, 34741, United States
ENT and Allergy Associates of Florida, LLC - Okeechobee
Okeechobee, Florida, 34972, United States
Central Florida Pulmonary Group
Orlando, Florida, 30803, United States
Central Florida Pulmonary Group - Dylan Loren Cir
Orlando, Florida, 32825, United States
Cancer Care Centers of Brevard
Palm Bay, Florida, 32901, United States
ENT and Allergy Associates of Florida, LLC
Palm Beach Gardens, Florida, 33410, United States
Woodlands Medical Specialists
Pensacola, Florida, 32503, United States
ENT and Allergy Associates of Florida, LLC
Plantation, Florida, 33324, United States
ENT and Allergy Associates of Florida, LLC
Port Saint Lucie, Florida, 34952, United States
Stuart Oncology Associates
Port Saint Lucie, Florida, 34952, United States
Stuart Oncology Associates
Port Saint Lucie, Florida, 34986, United States
Stuart Oncology Associates
Stuart, Florida, 34994, United States
ENT and Allergy Associates of Florida, LLC
Wesley Chapel, Florida, 33544, United States
ENT and Allergy Associates of Florida, LLC
West Palm Beach, Florida, 33401, United States
Advanced Urology - John's Creek
Johns Creek, Georgia, 30097, United States
Advanced Urology - Lawrenceville
Lawrenceville, Georgia, 30045, United States
Advanced Urology - Marietta
Marietta, Georgia, 30060, United States
Advanced Urology - Rosewell
Roswell, Georgia, 30076, United States
Advanced Urology - Snellville
Snellville, Georgia, 30078, United States
Illinois Cancer Specialists
Arlington Heights, Illinois, 60005, United States
Hope and Healing Cancer Services
Hinsdale, Illinois, 60521, United States
Hem/Onc of the North Shore
Skokie, Illinois, 60076, United States
Evansville Surgical Associates-Mary Street
Evansville, Indiana, 47710, United States
Evansville Surgical Associates-Mary's Drive
Evansville, Indiana, 47714, United States
Evansville Surgical Associates-Gateway Boulevard
Newburgh, Indiana, 47630, United States
Mission Cancer and Blood
Des Moines, Iowa, 50309, United States
Wichita Urology Group - W. 21st Street
Wichita, Kansas, 67205, United States
Wichita Urology Group- P.A. - 2077 N. Webb Road
Wichita, Kansas, 67206, United States
Breast Care Specialists
Wichita, Kansas, 67214, United States
Kansas Surgery & Recovery Center
Wichita, Kansas, 67226, United States
Wichita Urology Group- 2626 Webb Road
Wichita, Kansas, 67226, United States
Northlake Gastroenterology Associates
Hammond, Louisiana, 70403, United States
Northlake Gastroenterology Associates
Hammond, Louisiana, 70433, United States
Maryland Oncology Hematology
Columbia, Maryland, 21044, United States
Comprehensive Urology - Farmington Hills
Farmington Hills, Michigan, 48334, United States
Comprehensive Urology - Novi
Novi, Michigan, 48375, United States
Comprehensive Urology - Roseville
Roseville, Michigan, 48066, United States
Michigan Cancer Specialists
Roseville, Michigan, 48066, United States
Comprehensive Urology - Royal Oak
Royal Oak, Michigan, 48073, United States
Comprehensive Urology - Sterling Heights
Sterling Heights, Michigan, 48314, United States
Minnesota Oncology Hematology
Minneapolis, Minnesota, 55404, United States
Somnos Clinical Research
Lincoln, Nebraska, 68510, United States
Hope Cancer Care of Nevada
Las Vegas, Nevada, 89103, United States
Cancer Care Specialists - Reno
Reno, Nevada, 89511, United States
New Jersey Cancer Care
Belleville, New Jersey, 07109, United States
New Jersey Hematology Oncology Associates
Brick, New Jersey, 08724, United States
Surgical Specialists of New York - Jersey City
Jersey City, New Jersey, 07306, United States
Oncology Hematology Specialists
Mountain Lakes, New Jersey, 07046, United States
Center of Dermatology and Skin Surgery, LLC
Paramus, New Jersey, 07652, United States
Women's Cancer Care Associates LLC
Albany, New York, 12208, United States
Surgical Specialists of NY - Astoria
Astoria, New York, 11102, United States
New York Gastroenterology Associates - Pierrepont
Brooklyn, New York, 11201, United States
Gardith Joseph Medical P.C. Quality Cancer Care
Brooklyn, New York, 11234, United States
Vantage Medical Associates
Brooklyn, New York, 11234, United States
Associated Gastroenterologists of Central New York - Camillus
Camillus, New York, 13031, United States
Associated Gastroenterologists of Central New York - Syracuse
East Syracuse, New York, 13057, United States
Vantage Medical Associates
Far Rockaway, New York, 11691, United States
Associated Gastroenterologists of Central New York - Fayetteville
Fayetteville, New York, 13066, United States
Hudson Valley Cancer Center - Fishkill
Fishkill, New York, 12524, United States
Advanced Urology Centers of NY
Lake Success, New York, 11042, United States
Gastroenterology Oncology Associates
Liverpool, New York, 13088, United States
New York Gastroenterology Associates - Columbus Ave
New York, New York, 10024, United States
New York Gastroenterology Associates - 86th Street
New York, New York, 10028, United States
New York Gastroenterology Associates - E 79th St
New York, New York, 10075, United States
New York Gastroenterology Associates - 5th Ave
New York, New York, 10128, United States
Surgical Specialists of NY - New York City
New York, New York, 10128, United States
Advanced Radiation Oncology Services
Nyack, New York, 10960, United States
Hematology Oncology Associates of Rockland
Nyack, New York, 10960, United States
Hudson Valley Cancer Center - Poughkeepsie
Poughkeepsie, New York, 12601, United States
Premier Medical Group of the Hudson Valley
Poughkeepsie, New York, 12603, United States
Hirschfeld Oncology
The Bronx, New York, 10469, United States
Westmed Medical Group
Woodmere, New York, 11598, United States
Hudson Valley Cancer Center - Yorktown Heights
Yorktown Heights, New York, 10598, United States
Dayton Physicians Network
Dayton, Ohio, 45414, United States
Oncology Associates of Oregon
Eugene, Oregon, 97401, United States
Northwest Cancer Specialists-
Portland, Oregon, 97213, United States
Eastern Pennsylvania Gastroenterology & Liver Specialists, LLC
Allentown, Pennsylvania, 18104, United States
Blair Gastroenterology Associates
Altoona, Pennsylvania, 16648, United States
Consultants in Medical Oncology & Hematology
Broomall, Pennsylvania, 19008, United States
Pulmonology Associates INC.
Wynnewood, Pennsylvania, 19096, United States
Pulmonology Associates INC
Wynnewood, Pennsylvania, 19096, United States
Cancer Care Associates of York
York, Pennsylvania, 17403, United States
GIA Clinical Trials, LLC
Knoxville, Tennessee, 37909, United States
Advantage Clinical Research
Nashville, Tennessee, 37203, United States
HCA research Institute
Nashville, Tennessee, 37203, United States
Meharry Medical College
Nashville, Tennessee, 37208, United States
Urology Associates
Nashville, Tennessee, 37209, United States
Texas Oncology - West Texas
Amarillo, Texas, 79106, United States
Texas Oncology - Gulf Coast
Beaumont, Texas, 77702, United States
Texas Oncology - Dallas
Dallas, Texas, 75230, United States
Texas Oncology - Presbyterian Cancer Center Dallas
Dallas, Texas, 75231, United States
Texas Oncology-Baylor Charles A. Sammons Cancer Center
Dallas, Texas, 75246, United States
Texas Oncology-Fort Worth
Fort Worth, Texas, 76104, United States
Houston Digestive Diseases Consultants
Houston, Texas, 77074, United States
Texas Oncology - McAllen
McAllen, Texas, 78503, United States
Texas Oncology - Northeast Texas Cancer and Research
McKinney, Texas, 75071, United States
Texas Oncology - Plano East
Plano, Texas, 75075, United States
Texas Oncology - Plano West
Plano, Texas, 75093, United States
Texas Oncology - San Antonio
San Antonio, Texas, 78240, United States
Center for Digestive Disease
Shenandoah, Texas, 77384, United States
Texas Oncology - Northeast Texas Cancer and Research
Tyler, Texas, 75702, United States
Virginia Cancer Specialists
Fairfax, Virginia, 22031, United States
Virginia Oncology Associates
Norfolk, Virginia, 23502, United States
Shenandoah Oncology
Winchester, Virginia, 22601, United States
Northwest Medical Specialties, PLLC
Tacoma, Washington, 98405, United States
Biospecimen
* Tissue * Blood
MeSH Terms
Conditions
Study Officials
- STUDY CHAIR
Dax Kurbegov, MD
Sarah Cannon
- STUDY DIRECTOR
Hutan Ashrafian, MD MBA PhD
Harbinger Health
- STUDY CHAIR
Luke Pike, MD DPhil
Memorial Sloan Kettering Cancer Center
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 14, 2022
First Posted
June 28, 2022
Study Start
June 21, 2022
Primary Completion
June 11, 2025
Study Completion
June 11, 2025
Last Updated
July 29, 2025
Record last verified: 2025-07