Development and Validation of Harbinger Health Test for Early Cancer Detection

Study Overview
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Brief Summary
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This is a prospective, multi-center, observational study with a collection of biospecimens and clinical data from approximately 10,000 participants from up to 40 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.

Official Title
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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

Conditions
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Cancer

Intervention / Treatment
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* Diagnostic Test: Harbinger Health Test


Participation Criteria
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Eligibility Criteria
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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 (within 180 days prior to enrollment) of a type of cancer from the study list of cancer types for enrollment, including the following types: Stage I to Stage IV solid tumor cancer Non-solid (hematologic) cancer or - A high suspicion of cancer by imaging (within 180 days prior to enrollment) of a type of cancer from the study list of cancer types for enrollment, including the following types: Stage I to Stage IV solid tumor cancer Non-solid (hematologic) cancer For subjects to be enrolled with a confirmed cancer diagnosis, the subject's cancer diagnosis will be based upon assessment of a pathological specimen, 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). 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 has a known prior diagnosis of any other type of cancer (except completely resected ductal carcinoma in-situ or non-melanoma skin cancer) separate from the confirmed cancer diagnosis associated with study enrollment. 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. 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.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 79 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Arm 1 - cancer group<br>Arm 1 - newly diagnosed cancer subjects | Diagnostic Test: Harbinger Health Test<br>* 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 asymptomatic controls. The asymptomatic controls will be followed for up to 2 years<br>|
| Arm 2 - non cancer group<br>Arm 2 - non-cancer subjects | Diagnostic Test: Harbinger Health Test<br>* 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 asymptomatic controls. The asymptomatic controls will be followed for up to 2 years<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | upto 2 years | 
| 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 | upto 2 years | 
| 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 | upto 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cancer, early detection, blood-based cancer screening, cfDNA, cancer diagnosis