NCT07046260

Prospective Study to Assess a Diagnostic Aid for Cancer

Prospective Cohort Study With Case Enrichment to Assess a Diagnostic Aid for Cancer in Symptomatic Subjects (PROCARES)

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 1,650 (estimated)
• Sponsor: Harbinger Health · Industry
• Sex: All
• Age: 45 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of this study is to establish the performance of two blood-based diagnostic aid test for cancer detection in individuals presenting with symptoms, signs, or findings suggestive of cancer.

Detailed description

Subjects 45 years of age and older presenting with symptoms, signs, and/or findings suggestive of one or more cancers originating from protocol-specified sites will be enrolled. Subjects will complete a blood draw for analysis by the investigational diagnostic aid test. For subjects with suspected cancer at enrollment, clinical outcomes will be determined following completion of a standard-of-care diagnostic work-up as clinically indicated. Subjects with a confirmed cancer diagnosis at enrollment must be treatment-naïve and will have diagnosis details collected at the time of enrollment. The results of the investigational diagnostic aid test will not be provided to investigators, treating clinicians, or subjects. Personnel performing clinical evaluations, determining final diagnoses, or reviewing diagnostic imaging and pathology reports will remain blinded to the results of the investigational test. All testing and associated analyses will be conducted in a blinded fashion, and test results will not inform clinical decision-making.

Conditions

• Cancer

Interventions

Type	Name	Description
OTHER	Blood sample collection	The study will collect up to 40 mL of whole peripheral blood in Streck Cell-Free DNA BCT® tubes from each participant.

Timeline

• Start date: 2025-07-11
• Primary completion: 2026-07-01
• Completion: 2026-11-01
• First posted: 2025-07-01
• Last updated: 2026-03-11

Locations

39 sites across 1 country: United States