Development and Validation of Harbinger Health Test for Early Cancer Detection (CORE-HH)

Harbinger Health

Status

Enrolling

Conditions

Cancer

Treatments

Diagnostic Test: Harbinger Health Test

Study type

Observational

Funder types

Industry

Identifiers

NCT05435066

HH-PRT-0001

Tissue 32 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment

10,000 estimated patients

Sex

All

Ages

20 to 79 years old

Volunteers

Accepts Healthy Volunteers

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.