Development and Validation of Harbinger Health Test for Early Cancer Detection
- Conditions
- Cancer
- Interventions
- Diagnostic Test: Harbinger Health Test
- Registration Number
- NCT05435066
- Lead Sponsor
- Harbinger Health
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 10000
- 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
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 & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Arm 1 - cancer group Harbinger Health Test Arm 1 - newly diagnosed cancer subjects Arm 2 - non cancer group Harbinger Health Test Arm 2 - non-cancer subjects (Not currently enrolling in this arm)
- Primary Outcome Measures
Name Time Method Detection of cancer or non-cancer using Harbinger Test 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
Performance for specific cancer types using Harbinger Test 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
Identify the correct tumor type by Harbinger Test 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
- Secondary Outcome Measures
Name Time Method Evaluate performance of the Harbinger Health Test by tumor stage Up to 12 months Assess Harbinger Health test performance with repeat of primary subgroup analysis through Tumor Stage within Cancer Type.
Evaluate performance of the Harbinger Health Test to discriminate hyperplasia Advanced Adenoma. Up to 12 months Assess Harbinger Health test performance by repeat of Primary with Subgroup Analysis of Non-Cancer vs. Hyperplasia (Advanced Adenoma).
Trial Locations
- Locations (114)
Southern Cancer Center
🇺🇸Daphne, Alabama, United States
Alaska Oncology and Hematology, LLC
🇺🇸Anchorage, Alaska, United States
Alaska Womens Cancer Care
🇺🇸Anchorage, Alaska, United States
Arizona Oncology Associates HAL
🇺🇸Prescott Valley, Arizona, United States
Pacific Cancer Medical Center
🇺🇸Anaheim, California, United States
Central California ENT Medical Group
🇺🇸Fresno, California, United States
South Coast Gynecologic Oncology, Inc
🇺🇸San Diego, California, United States
South Coast Gynecologic Oncology, INC
🇺🇸San Diego, California, United States
Sansum Clinic
🇺🇸Santa Barbara, California, United States
Gynecologic Oncology Associates
🇺🇸Torrance, California, United States
Colorado Primary Health Care
🇺🇸Littleton, Colorado, United States
Medical Oncology Hematology Consultants, PA
🇺🇸Newark, Delaware, United States
Central Florida Pulmonary Group - Altamonte Springs
🇺🇸Altamonte Springs, Florida, United States
ENT and Allergy Associates of Florida, LLC
🇺🇸West Palm Beach, Florida, United States
Plastic Surgery Specialists of Boca Raton
🇺🇸Boca Raton, Florida, United States
South Florida Center for Gynecologic Oncology
🇺🇸Boca Raton, Florida, United States
Urology Center of South Florida
🇺🇸Boynton Beach, Florida, United States
Advanced Cancer Surgery and Digestive Health
🇺🇸Boynton Beach, Florida, United States
Zoyla Almedia, MD PA
🇺🇸Coconut Creek, Florida, United States
Stuart Oncology Associates
🇺🇸Stuart, Florida, United States
I.H.S. Health
🇺🇸Kissimmee, Florida, United States
ENT and Allergy Associates of Florida, LLC - Okeechobee
🇺🇸Okeechobee, Florida, United States
Central Florida Pulmonary Group
🇺🇸Orlando, Florida, United States
Central Florida Pulmonary Group - Dylan Loren Cir
🇺🇸Orlando, Florida, United States
Cancer Care Centers of Brevard
🇺🇸Palm Bay, Florida, United States
Woodlands Medical Specialists
🇺🇸Pensacola, Florida, United States
Advanced Urology - John's Creek
🇺🇸Johns Creek, Georgia, United States
Advanced Urology - Lawrenceville
🇺🇸Lawrenceville, Georgia, United States
Advanced Urology - Marietta
🇺🇸Marietta, Georgia, United States
Advanced Urology - Rosewell
🇺🇸Roswell, Georgia, United States
Advanced Urology - Snellville
🇺🇸Snellville, Georgia, United States
Illinois Cancer Specialists
🇺🇸Arlington Heights, Illinois, United States
Hope and Healing Cancer Services
🇺🇸Hinsdale, Illinois, United States
Hem/Onc of the North Shore
🇺🇸Skokie, Illinois, United States
Evansville Surgical Associates-Mary Street
🇺🇸Evansville, Indiana, United States
Evansville Surgical Associates-Mary's Drive
🇺🇸Evansville, Indiana, United States
Evansville Surgical Associates-Gateway Boulevard
🇺🇸Newburgh, Indiana, United States
Mission Cancer and Blood
🇺🇸Des Moines, Iowa, United States
Wichita Urology Group - W. 21st Street
🇺🇸Wichita, Kansas, United States
Wichita Urology Group- P.A. - 2077 N. Webb Road
🇺🇸Wichita, Kansas, United States
Breast Care Specialists
🇺🇸Wichita, Kansas, United States
Kansas Surgery & Recovery Center
🇺🇸Wichita, Kansas, United States
Wichita Urology Group- 2626 Webb Road
🇺🇸Wichita, Kansas, United States
Northlake Gastroenterology Associates
🇺🇸Hammond, Louisiana, United States
Maryland Oncology Hematology
🇺🇸Columbia, Maryland, United States
Comprehensive Urology - Farmington Hills
🇺🇸Farmington Hills, Michigan, United States
Comprehensive Urology - Novi
🇺🇸Novi, Michigan, United States
Comprehensive Urology - Roseville
🇺🇸Roseville, Michigan, United States
Michigan Cancer Specialists
🇺🇸Roseville, Michigan, United States
Comprehensive Urology - Royal Oak
🇺🇸Royal Oak, Michigan, United States
Comprehensive Urology - Sterling Heights
🇺🇸Sterling Heights, Michigan, United States
Minnesota Oncology Hematology
🇺🇸Minneapolis, Minnesota, United States
Somnos Clinical Research
🇺🇸Lincoln, Nebraska, United States
Hope Cancer Care of Nevada
🇺🇸Las Vegas, Nevada, United States
Cancer Care Specialists - Reno
🇺🇸Reno, Nevada, United States
New Jersey Cancer Care
🇺🇸Belleville, New Jersey, United States
New Jersey Hematology Oncology Associates
🇺🇸Brick, New Jersey, United States
Surgical Specialists of New York - Jersey City
🇺🇸Jersey City, New Jersey, United States
Oncology Hematology Specialists
🇺🇸Mountain Lakes, New Jersey, United States
Center of Dermatology and Skin Surgery, LLC
🇺🇸Paramus, New Jersey, United States
Women's Cancer Care Associates LLC
🇺🇸Albany, New York, United States
Surgical Specialists of NY - Astoria
🇺🇸Astoria, New York, United States
Hirschfeld Oncology
🇺🇸Bronx, New York, United States
New York Gastroenterology Associates - Pierrepont
🇺🇸Brooklyn, New York, United States
Gardith Joseph Medical P.C. Quality Cancer Care
🇺🇸Brooklyn, New York, United States
Vantage Medical Associates
🇺🇸Far Rockaway, New York, United States
Associated Gastroenterologists of Central New York - Camillus
🇺🇸Camillus, New York, United States
Associated Gastroenterologists of Central New York - Syracuse
🇺🇸East Syracuse, New York, United States
Associated Gastroenterologists of Central New York - Fayetteville
🇺🇸Fayetteville, New York, United States
Hudson Valley Cancer Center - Fishkill
🇺🇸Fishkill, New York, United States
Advanced Urology Centers of NY
🇺🇸Lake Success, New York, United States
Gastroenterology Oncology Associates
🇺🇸Liverpool, New York, United States
New York Gastroenterology Associates - Columbus Ave
🇺🇸New York, New York, United States
New York Gastroenterology Associates - E 79th St
🇺🇸New York, New York, United States
Surgical Specialists of NY - New York City
🇺🇸New York City, New York, United States
New York Gastroenterology Associates - 86th Street
🇺🇸New York, New York, United States
Advanced Radiation Oncology Services
🇺🇸Nyack, New York, United States
Hematology Oncology Associates of Rockland
🇺🇸Nyack, New York, United States
Hudson Valley Cancer Center - Poughkeepsie
🇺🇸Poughkeepsie, New York, United States
New York Gastroenterology Associates - 5th Ave
🇺🇸New York, New York, United States
Premier Medical Group of the Hudson Valley
🇺🇸Poughkeepsie, New York, United States
Westmed Medical Group
🇺🇸Woodmere, New York, United States
Hudson Valley Cancer Center - Yorktown Heights
🇺🇸Yorktown Heights, New York, United States
Dayton Physicians Network
🇺🇸Dayton, Ohio, United States
Oncology Associates of Oregon
🇺🇸Eugene, Oregon, United States
Pulmonology Associates INC
🇺🇸Wynnewood, Pennsylvania, United States
Cancer Care Associates of York
🇺🇸York, Pennsylvania, United States
GIA Clinical Trials, LLC
🇺🇸Knoxville, Tennessee, United States
Advantage Clinical Research
🇺🇸Nashville, Tennessee, United States
HCA research Institute
🇺🇸Nashville, Tennessee, United States
Meharry Medical College
🇺🇸Nashville, Tennessee, United States
Urology Associates
🇺🇸Nashville, Tennessee, United States
Texas Oncology - West Texas
🇺🇸Amarillo, Texas, United States
Texas Oncology - Gulf Coast
🇺🇸Beaumont, Texas, United States
Texas Oncology - Dallas
🇺🇸Dallas, Texas, United States
Texas Oncology - Presbyterian Cancer Center Dallas
🇺🇸Dallas, Texas, United States
Texas Oncology-Baylor Charles A. Sammons Cancer Center
🇺🇸Dallas, Texas, United States
Texas Oncology-Fort Worth
🇺🇸Fort Worth, Texas, United States
Houston Digestive Diseases Consultants
🇺🇸Houston, Texas, United States
Texas Oncology - McAllen
🇺🇸McAllen, Texas, United States
Texas Oncology - Northeast Texas Cancer and Research
🇺🇸Tyler, Texas, United States
Texas Oncology - Plano East
🇺🇸Plano, Texas, United States
Northwest Cancer Specialists-
🇺🇸Portland, Oregon, United States
Eastern Pennsylvania Gastroenterology & Liver Specialists, LLC
🇺🇸Allentown, Pennsylvania, United States
Blair Gastroenterology Associates
🇺🇸Altoona, Pennsylvania, United States
Consultants in Medical Oncology & Hematology
🇺🇸Broomall, Pennsylvania, United States
Pulmonology Associates INC.
🇺🇸Wynnewood, Pennsylvania, United States
Texas Oncology - Plano West
🇺🇸Plano, Texas, United States
Texas Oncology - San Antonio
🇺🇸San Antonio, Texas, United States
Center for Digestive Disease
🇺🇸Shenandoah, Texas, United States
Virginia Cancer Specialists
🇺🇸Fairfax, Virginia, United States
Virginia Oncology Associates
🇺🇸Norfolk, Virginia, United States
Shenandoah Oncology
🇺🇸Winchester, Virginia, United States
Northwest Medical Specialties, PLLC
🇺🇸Tacoma, Washington, United States