NCT05435066

Development and Validation of Harbinger Health Test for Early Cancer Detection

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 8,038 (actual)
• Sponsor: Harbinger Health · Industry
• Sex: All
• Age: 20 Years – 79 Years
• Healthy volunteers: Accepted

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.

Conditions

• Cancer

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Harbinger 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

Timeline

• Start date: 2022-06-21
• Primary completion: 2025-06-11
• Completion: 2025-06-11
• First posted: 2022-06-28
• Last updated: 2025-07-29

Locations

128 sites across 1 country: United States