Cancer
Conditions
Keywords
cancer, early detection, blood-based cancer screening, cfDNA, cancer diagnosis
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.
Interventions
DIAGNOSTIC_TESTHarbinger 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
Sponsors
Harbinger Health
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
20 Years to 79 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Detection of cancer or non-cancer using Harbinger Test | Up to 12 months | 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 |
| Performance for specific cancer types using Harbinger Test | Up to 12 months | Sub-analysis by clinical diagnosis of cancer type (e.g. Breast cancer) to determine how well the Harbinger Health test detects specific tumor types |
| Identify the correct tumor type by Harbinger Test | Up to 12 months | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Evaluate performance of the Harbinger Health Test by tumor stage | Up to 12 months | Assess Harbinger Health test performance with repeat of primary subgroup analysis through Tumor Stage within Cancer Type. |
| Evaluate performance of the Harbinger Health Test to discriminate hyperplasia Advanced Adenoma. | Up to 12 months | Assess Harbinger Health test performance by repeat of Primary with Subgroup Analysis of Non-Cancer vs. Hyperplasia (Advanced Adenoma). |
Countries
United States
Outcome results
None listed