Development and Validation of Harbinger Health Test for Early Cancer Detection

Cancer Clinical Trial

— CORE-HH  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05435066
• Other study ID #: HH-PRT-0001
• Secondary ID: Tissue 32
• Status: Recruiting
• Start date: June 21, 2022
• Est. completion date: July 3, 2026

Study information

• Verified date: April 2024
• Source: Harbinger Health
• Contact: Sarah Cannon Development Innovations, LLC
• Phone: 844-710-6157
• Email: SCRI.InnovationsMedical[@]scri.com
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10000
• Est. completion date: July 3, 2026
• Est. primary completion date: December 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 79 Years

Eligibility

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.

Related Conditions & MeSH terms

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

Locations

Country	Name	City	State
United States	Women's Cancer Care Associates LLC	Albany	New York
United States	Eastern Pennsylvania Gastroenterology & Liver Specialists, LLC	Allentown	Pennsylvania
United States	Central Florida Pulmonary Group - Altamonte Springs	Altamonte Springs	Florida
United States	Blair Gastroenterology Associates	Altoona	Pennsylvania
United States	Texas Oncology - West Texas	Amarillo	Texas
United States	Pacific Cancer Medical Center	Anaheim	California
United States	Alaska Oncology and Hematology, LLC	Anchorage	Alaska
United States	Alaska Womens Cancer Care	Anchorage	Alaska
United States	Illinois Cancer Specialists	Arlington Heights	Illinois
United States	Surgical Specialists of NY - Astoria	Astoria	New York
United States	Texas Oncology - Gulf Coast	Beaumont	Texas
United States	New Jersey Cancer Care	Belleville	New Jersey
United States	ENT and Allergy Associates of Florida, LLC	Boca Raton	Florida
United States	ENT and Allergy Associates of Florida, LLC	Boca Raton	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	Advanced Cancer Surgery and Digestive Health	Boynton Beach	Florida
United States	Urology Center of South Florida	Boynton Beach	Florida
United States	ENT and Allergy Associates of Florida, LLC	Brandon	Florida
United States	New Jersey Hematology Oncology Associates	Brick	New Jersey
United States	Hirschfeld Oncology	Bronx	New York
United States	Gardith Joseph Medical P.C. Quality Cancer Care	Brooklyn	New York
United States	New York Gastroenterology Associates - Pierrepont	Brooklyn	New York
United States	Vantage Medical Associates	Brooklyn	New York
United States	Consultants in Medical Oncology & Hematology	Broomall	Pennsylvania
United States	Associated Gastroenterologists of Central New York - Camillus	Camillus	New York
United States	Zoyla Almedia, MD PA	Coconut Creek	Florida
United States	Maryland Oncology Hematology	Columbia	Maryland
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	Southern Cancer Center	Daphne	Alabama
United States	Dayton Physicians Network	Dayton	Ohio
United States	Mission Cancer and Blood	Des Moines	Iowa
United States	Associated Gastroenterologists of Central New York - Syracuse	East Syracuse	New York
United States	Oncology Associates of Oregon	Eugene	Oregon
United States	Virginia Cancer Specialists	Fairfax	Virginia
United States	Vantage Medical Associates	Far Rockaway	New York
United States	Comprehensive Urology - Farmington Hills	Farmington Hills	Michigan
United States	Associated Gastroenterologists of Central New York - Fayetteville	Fayetteville	New York
United States	Hudson Valley Cancer Center - Fishkill	Fishkill	New York
United States	ENT and Allergy Associates of Florida, LLC	Fort Pierce	Florida
United States	Stuart Oncology Associates	Fort Pierce	Florida
United States	Texas Oncology-Fort Worth	Fort Worth	Texas
United States	Central California ENT Medical Group	Fresno	California
United States	Northlake Gastroenterology Associates	Hammond	Louisiana
United States	Northlake Gastroenterology Associates	Hammond	Louisiana
United States	Hope and Healing Cancer Services	Hinsdale	Illinois
United States	Houston Digestive Diseases Consultants	Houston	Texas
United States	Surgical Specialists of New York - Jersey City	Jersey City	New Jersey
United States	Advanced Urology - John's Creek	Johns Creek	Georgia
United States	I.H.S. Health	Kissimmee	Florida
United States	GIA Clinical Trials, LLC	Knoxville	Tennessee
United States	Advanced Urology Centers of NY	Lake Success	New York
United States	Hope Cancer Care of Nevada	Las Vegas	Nevada
United States	Advanced Urology - Lawrenceville	Lawrenceville	Georgia
United States	Somnos Clinical Research	Lincoln	Nebraska
United States	Colorado Primary Health Care	Littleton	Colorado
United States	Gastroenterology Oncology Associates	Liverpool	New York
United States	Advanced Urology - Marietta	Marietta	Georgia
United States	Texas Oncology - McAllen	McAllen	Texas
United States	Texas Oncology - Northeast Texas Cancer and Research	McKinney	Texas
United States	Minnesota Oncology Hematology	Minneapolis	Minnesota
United States	Oncology Hematology Specialists	Mountain Lakes	New Jersey
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	New York Gastroenterology Associates - 5th Ave	New York	New York
United States	New York Gastroenterology Associates - 86th Street	New York	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	New York
United States	Medical Oncology Hematology Consultants, PA	Newark	Delaware
United States	Virginia Oncology Associates	Norfolk	Virginia
United States	Comprehensive Urology - Novi	Novi	Michigan
United States	Advanced Radiation Oncology Services	Nyack	New York
United States	Hematology Oncology Associates of Rockland	Nyack	New York
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	ENT and Allergy Associates of Florida, LLC	Palm Beach Gardens	Florida
United States	Center of Dermatology and Skin Surgery, LLC	Paramus	New Jersey
United States	Woodlands Medical Specialists	Pensacola	Florida
United States	Texas Oncology - Plano East	Plano	Texas
United States	Texas Oncology - Plano West	Plano	Texas
United States	ENT and Allergy Associates of Florida, LLC	Plantation	Florida
United States	ENT and Allergy Associates of Florida, LLC	Port Saint Lucie	Florida
United States	Stuart Oncology Associates	Port Saint Lucie	Florida
United States	Stuart Oncology Associates	Port Saint Lucie	Florida
United States	Northwest Cancer Specialists-	Portland	Oregon
United States	Hudson Valley Cancer Center - Poughkeepsie	Poughkeepsie	New York
United States	Premier Medical Group of the Hudson Valley	Poughkeepsie	New York
United States	Arizona Oncology Associates HAL	Prescott Valley	Arizona
United States	Cancer Care Specialists - Reno	Reno	Nevada
United States	Comprehensive Urology - Roseville	Roseville	Michigan
United States	Michigan Cancer Specialists	Roseville	Michigan
United States	Advanced Urology - Rosewell	Roswell	Georgia
United States	Comprehensive Urology - Royal Oak	Royal Oak	Michigan
United States	Texas Oncology - San Antonio	San Antonio	Texas
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	Center for Digestive Disease	Shenandoah	Texas
United States	Hem/Onc of the North Shore	Skokie	Illinois
United States	Advanced Urology - Snellville	Snellville	Georgia
United States	Comprehensive Urology - Sterling Heights	Sterling Heights	Michigan
United States	Stuart Oncology Associates	Stuart	Florida
United States	Northwest Medical Specialties, PLLC	Tacoma	Washington
United States	Gynecologic Oncology Associates	Torrance	California
United States	Texas Oncology - Northeast Texas Cancer and Research	Tyler	Texas
United States	ENT and Allergy Associates of Florida, LLC	Wesley Chapel	Florida
United States	ENT and Allergy Associates of Florida, LLC	West Palm Beach	Florida
United States	Breast Care Specialists	Wichita	Kansas
United States	Kansas Surgery & Recovery Center	Wichita	Kansas
United States	Wichita Urology Group - W. 21st Street	Wichita	Kansas
United States	Wichita Urology Group- 2626 Webb Road	Wichita	Kansas
United States	Wichita Urology Group- P.A. - 2077 N. Webb Road	Wichita	Kansas
United States	Shenandoah Oncology	Winchester	Virginia
United States	Westmed Medical Group	Woodmere	New York
United States	Pulmonology Associates INC	Wynnewood	Pennsylvania
United States	Pulmonology Associates INC.	Wynnewood	Pennsylvania
United States	Cancer Care Associates of York	York	Pennsylvania
United States	Hudson Valley Cancer Center - Yorktown Heights	Yorktown Heights	New York

Sponsors (1)

Lead Sponsor	Collaborator
Harbinger Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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.	Up to 12 months
Secondary	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).	Up to 12 months