Clinical trial NCT05435066: Development and Validation of Harbinger Health Test for Early Cancer Detection
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
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Cancer
Keywords: cancer
early detection
blood-based cancer screening
cfDNA
cancer diagnosis
Lead sponsor: Harbinger Health
Sponsor class: INDUSTRY
First posted: 2022-06-28
Enrollment: 10000
Sex: ALL
Minimum age (years): 20
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Newly diagnosed cancer subjects and non-cancer subjects

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Detection of cancer or non-cancer using Harbinger Test
timeFrame: Up to 12 months
measure: Performance for specific cancer types using Harbinger Test
timeFrame: Up to 12 months
measure: Identify the correct tumor type by Harbinger Test
timeFrame: Up to 12 months
Secondary outcomes:
measure: Evaluate performance of the Harbinger Health Test by tumor stage
timeFrame: Up to 12 months
measure: Evaluate performance of the Harbinger Health Test to discriminate hyperplasia Advanced Adenoma.
timeFrame: Up to 12 months
Other outcomes:
Locations:
city: Daphne
country: United States
facility: Southern Cancer Center
state: Alabama
city: Anchorage
country: United States
facility: Alaska Oncology and Hematology, LLC
state: Alaska
city: Anchorage
country: United States
facility: Alaska Womens Cancer Care
state: Alaska
city: Prescott Valley
country: United States
facility: Arizona Oncology Associates HAL
state: Arizona
city: Anaheim
country: United States
facility: Pacific Cancer Medical Center
state: California
city: Fresno
country: United States
facility: Central California ENT Medical Group
state: California
city: San Diego
country: United States
facility: South Coast Gynecologic Oncology, Inc
state: California
city: San Diego
country: United States
facility: South Coast Gynecologic Oncology, INC
state: California
city: Santa Barbara
country: United States
facility: Sansum Clinic
state: California
city: Torrance
country: United States
facility: Gynecologic Oncology Associates
state: California
city: Littleton
country: United States
facility: Colorado Primary Health Care
state: Colorado
city: Newark
country: United States
facility: Medical Oncology Hematology Consultants, PA
state: Delaware
city: Altamonte Springs
country: United States
facility: Central Florida Pulmonary Group - Altamonte Springs
state: Florida
city: Boca Raton
country: United States
facility: ENT and Allergy Associates of Florida, LLC
state: Florida
city: Boca Raton
country: United States
facility: Plastic Surgery Specialists of Boca Raton
state: Florida
city: Boca Raton
country: United States
facility: ENT and Allergy Associates of Florida, LLC
state: Florida
city: Boca Raton
country: United States
facility: South Florida Center for Gynecologic Oncology
state: Florida
city: Boynton Beach
country: United States
facility: Urology Center of South Florida
state: Florida
city: Boynton Beach
country: United States
facility: Advanced Cancer Surgery and Digestive Health
state: Florida
city: Brandon
country: United States
facility: ENT and Allergy Associates of Florida, LLC
state: Florida
city: Coconut Creek
country: United States
facility: Zoyla Almedia, MD PA
state: Florida
city: Fort Pierce
country: United States
facility: ENT and Allergy Associates of Florida, LLC
state: Florida
city: Fort Pierce
country: United States
facility: Stuart Oncology Associates
state: Florida
city: Kissimmee
country: United States
facility: I.H.S. Health
state: Florida
city: Okeechobee
country: United States
facility: ENT and Allergy Associates of Florida, LLC - Okeechobee
state: Florida
city: Orlando
country: United States
facility: Central Florida Pulmonary Group
state: Florida
city: Orlando
country: United States
facility: Central Florida Pulmonary Group - Dylan Loren Cir
state: Florida
city: Palm Bay
country: United States
facility: Cancer Care Centers of Brevard
state: Florida
city: Palm Beach Gardens
country: United States
facility: ENT and Allergy Associates of Florida, LLC
state: Florida
city: Pensacola
country: United States
facility: Woodlands Medical Specialists
state: Florida
city: Plantation
country: United States
facility: ENT and Allergy Associates of Florida, LLC
state: Florida
city: Port St. Lucie
country: United States
facility: ENT and Allergy Associates of Florida, LLC
state: Florida
city: Port St. Lucie
country: United States
facility: Stuart Oncology Associates
state: Florida
city: Port St. Lucie
country: United States
facility: Stuart Oncology Associates
state: Florida
city: Stuart
country: United States
facility: Stuart Oncology Associates
state: Florida
city: Wesley Chapel
country: United States
facility: ENT and Allergy Associates of Florida, LLC
state: Florida
city: West Palm Beach
country: United States
facility: ENT and Allergy Associates of Florida, LLC
state: Florida
city: Johns Creek
country: United States
facility: Advanced Urology - John's Creek
state: Georgia
city: Lawrenceville
country: United States
facility: Advanced Urology - Lawrenceville
state: Georgia
city: Marietta
country: United States
facility: Advanced Urology - Marietta
state: Georgia
city: Roswell
country: United States
facility: Advanced Urology - Rosewell
state: Georgia
city: Snellville
country: United States
facility: Advanced Urology - Snellville
state: Georgia
city: Arlington Heights
country: United States
facility: Illinois Cancer Specialists
state: Illinois
city: Hinsdale
country: United States
facility: Hope and Healing Cancer Services
state: Illinois
city: Skokie
country: United States
facility: Hem/Onc of the North Shore
state: Illinois
city: Evansville
country: United States
facility: Evansville Surgical Associates-Mary Street
state: Indiana
city: Evansville
country: United States
facility: Evansville Surgical Associates-Mary's Drive
state: Indiana
city: Newburgh
country: United States
facility: Evansville Surgical Associates-Gateway Boulevard
state: Indiana
city: Des Moines
country: United States
facility: Mission Cancer and Blood
state: Iowa
city: Wichita
country: United States
facility: Wichita Urology Group - W. 21st Street
state: Kansas
city: Wichita
country: United States
facility: Wichita Urology Group- P.A. - 2077 N. Webb Road
state: Kansas
city: Wichita
country: United States
facility: Breast Care Specialists
state: Kansas
city: Wichita
country: United States
facility: Kansas Surgery & Recovery Center
state: Kansas
city: Wichita
country: United States
facility: Wichita Urology Group- 2626 Webb Road
state: Kansas
city: Hammond
country: United States
facility: Northlake Gastroenterology Associates
state: Louisiana
city: Hammond
country: United States
facility: Northlake Gastroenterology Associates
state: Louisiana
city: Columbia
country: United States
facility: Maryland Oncology Hematology
state: Maryland
city: Farmington Hills
country: United States
facility: Comprehensive Urology - Farmington Hills
state: Michigan
city: Novi
country: United States
facility: Comprehensive Urology - Novi
state: Michigan
city: Roseville
country: United States
facility: Comprehensive Urology - Roseville
state: Michigan
city: Roseville
country: United States
facility: Michigan Cancer Specialists
state: Michigan
city: Royal Oak
country: United States
facility: Comprehensive Urology - Royal Oak
state: Michigan
city: Sterling Heights
country: United States
facility: Comprehensive Urology - Sterling Heights
state: Michigan
city: Minneapolis
country: United States
facility: Minnesota Oncology Hematology
state: Minnesota
city: Lincoln
country: United States
facility: Somnos Clinical Research
state: Nebraska
city: Las Vegas
country: United States
facility: Hope Cancer Care of Nevada
state: Nevada
city: Reno
country: United States
facility: Cancer Care Specialists - Reno
state: Nevada
city: Belleville
country: United States
facility: New Jersey Cancer Care
state: New Jersey
city: Brick
country: United States
facility: New Jersey Hematology Oncology Associates
state: New Jersey
city: Jersey City
country: United States
facility: Surgical Specialists of New York - Jersey City
state: New Jersey
city: Mountain Lakes
country: United States
facility: Oncology Hematology Specialists
state: New Jersey
city: Paramus
country: United States
facility: Center of Dermatology and Skin Surgery, LLC
state: New Jersey
city: Albany
country: United States
facility: Women's Cancer Care Associates LLC
state: New York
city: Astoria
country: United States
facility: Surgical Specialists of NY - Astoria
state: New York
city: Bronx
country: United States
facility: Hirschfeld Oncology
state: New York
city: Brooklyn
country: United States
facility: New York Gastroenterology Associates - Pierrepont
state: New York
city: Brooklyn
country: United States
facility: Gardith Joseph Medical P.C. Quality Cancer Care
state: New York
city: Brooklyn
country: United States
facility: Vantage Medical Associates
state: New York
city: Camillus
country: United States
facility: Associated Gastroenterologists of Central New York - Camillus
state: New York
city: East Syracuse
country: United States
facility: Associated Gastroenterologists of Central New York - Syracuse
state: New York
city: Far Rockaway
country: United States
facility: Vantage Medical Associates
state: New York
city: Fayetteville
country: United States
facility: Associated Gastroenterologists of Central New York - Fayetteville
state: New York
city: Fishkill
country: United States
facility: Hudson Valley Cancer Center - Fishkill
state: New York
city: Lake Success
country: United States
facility: Advanced Urology Centers of NY
state: New York
city: Liverpool
country: United States
facility: Gastroenterology Oncology Associates
state: New York
city: New York City
country: United States
facility: Surgical Specialists of NY - New York City
state: New York
city: New York
country: United States
facility: New York Gastroenterology Associates - Columbus Ave
state: New York
city: New York
country: United States
facility: New York Gastroenterology Associates - 86th Street
state: New York
city: New York
country: United States
facility: New York Gastroenterology Associates - E 79th St
state: New York
city: New York
country: United States
facility: New York Gastroenterology Associates - 5th Ave
state: New York
city: Nyack
country: United States
facility: Advanced Radiation Oncology Services
state: New York
city: Nyack
country: United States
facility: Hematology Oncology Associates of Rockland
state: New York
city: Poughkeepsie
country: United States
facility: Hudson Valley Cancer Center - Poughkeepsie
state: New York
city: Poughkeepsie
country: United States
facility: Premier Medical Group of the Hudson Valley
state: New York
city: Woodmere
country: United States
facility: Westmed Medical Group
state: New York
city: Yorktown Heights
country: United States
facility: Hudson Valley Cancer Center - Yorktown Heights
state: New York
city: Dayton
country: United States
facility: Dayton Physicians Network
state: Ohio
city: Eugene
country: United States
facility: Oncology Associates of Oregon
state: Oregon
city: Portland
country: United States
facility: Northwest Cancer Specialists-
state: Oregon
city: Allentown
country: United States
facility: Eastern Pennsylvania Gastroenterology & Liver Specialists, LLC
state: Pennsylvania
city: Altoona
country: United States
facility: Blair Gastroenterology Associates
state: Pennsylvania
city: Broomall
country: United States
facility: Consultants in Medical Oncology & Hematology
state: Pennsylvania
city: Wynnewood
country: United States
facility: Pulmonology Associates INC.
state: Pennsylvania
city: Wynnewood
country: United States
facility: Pulmonology Associates INC
state: Pennsylvania
city: York
country: United States
facility: Cancer Care Associates of York
state: Pennsylvania
city: Knoxville
country: United States
facility: GIA Clinical Trials, LLC
state: Tennessee
city: Nashville
country: United States
facility: Advantage Clinical Research
state: Tennessee
city: Nashville
country: United States
facility: HCA research Institute
state: Tennessee
city: Nashville
country: United States
facility: Meharry Medical College
state: Tennessee
city: Nashville
country: United States
facility: Urology Associates
state: Tennessee
city: Amarillo
country: United States
facility: Texas Oncology - West Texas
state: Texas
city: Beaumont
country: United States
facility: Texas Oncology - Gulf Coast
state: Texas
city: Dallas
country: United States
facility: Texas Oncology - Dallas
state: Texas
city: Dallas
country: United States
facility: Texas Oncology - Presbyterian Cancer Center Dallas
state: Texas
city: Dallas
country: United States
facility: Texas Oncology-Baylor Charles A. Sammons Cancer Center
state: Texas
city: Fort Worth
country: United States
facility: Texas Oncology-Fort Worth
state: Texas
city: Houston
country: United States
facility: Houston Digestive Diseases Consultants
state: Texas
city: McAllen
country: United States
facility: Texas Oncology - McAllen
state: Texas
city: McKinney
country: United States
facility: Texas Oncology - Northeast Texas Cancer and Research
state: Texas
city: Plano
country: United States
facility: Texas Oncology - Plano East
state: Texas
city: Plano
country: United States
facility: Texas Oncology - Plano West
state: Texas
city: San Antonio
country: United States
facility: Texas Oncology - San Antonio
state: Texas
city: Shenandoah
country: United States
facility: Center for Digestive Disease
state: Texas
city: Tyler
country: United States
facility: Texas Oncology - Northeast Texas Cancer and Research
state: Texas
city: Fairfax
country: United States
facility: Virginia Cancer Specialists
state: Virginia
city: Norfolk
country: United States
facility: Virginia Oncology Associates
state: Virginia
city: Winchester
country: United States
facility: Shenandoah Oncology
state: Virginia
city: Tacoma
country: United States
facility: Northwest Medical Specialties, PLLC
state: Washington
Study officials:
affiliation: Sarah Cannon
name: Dax Kurbegov, MD
role: STUDY_CHAIR
affiliation: Harbinger Health
name: Hutan Ashrafian, MD MBA PhD
role: STUDY_DIRECTOR
affiliation: Memorial Sloan Kettering Cancer Center
name: Luke Pike, MD DPhil
role: STUDY_CHAIR
References: