Mountain Lakes

Researchers are evaluating the performance of two blood-based diagnostic tests designed to help detect cancer in individuals aged 45 and older who show symptoms, signs, or findings that suggest cancer. The study aims to assess these tests in people suspected of having cancer or those recently diagnosed but not yet treated. This observational study is sponsored by Harbinger Health and focuses on cancers originating from specific sites outlined in the study protocol. Participants will provide a blood sample of up to 40 mL collected in special tubes for analysis by the investigational diagnostic tests. Those with suspected cancer will undergo a standard diagnostic work-up to confirm if cancer is present, while those already diagnosed must be treatment-nave. The results of the diagnostic tests will not be shared with patients or doctors and will not influence clinical decisions. All testing and analyses are conducted in a blinded manner. During the study, participants will complete a blood draw and follow the usual diagnostic procedures as needed. Researchers will track clinical outcomes, diagnostic test performance, and cancer incidence over 18 months. The main measure is how well the two diagnostic tests identify cancer among participants showing relevant symptoms or signs. Safety and adherence will be monitored, but the study does not involve treatment. Total participation duration may vary depending on diagnostic and follow-up processes.