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.
Study Type
OBSERVATIONAL
Enrollment
8,038
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
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
Time frame: Up to 12 months
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
Time frame: Up to 12 months
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
Time frame: Up to 12 months
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.
Time frame: Up to 12 months
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).
Time frame: Up to 12 months
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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
...and 118 more locations