NCT04052048

Active Surveillance SNEP Assay Registry Trial for Prostate Cancer

A Multi-center, Prospective Active Surveillance Registry Trial Assessing the Performance of a Non-invasive Immunogenomic Blood Test for Indolent Prostate Cancer Disease Management.

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 2,000 (estimated)
• Sponsor: Immunis.AI · Industry
• Sex: Male
• Age: 40 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

A multi-center, prospective active surveillance registry trial assessing the performance of a non-invasive blood test for indolent prostate cancer disease management.

Detailed description

The analysis population is defined as all the set of de-identified patient results received from the practices who met the inclusion / exclusion criteria. A target recruitment of 2000 subjects with an expected loss of 20% (400 subjects) and an overall event rate of 30% (480 subjects of 1600) will result in 480 cases and 1120 controls, where cases are defined as those patients with NCCN unfavorable intermediate risk or worse disease. With a significance level alpha of 0.05, the number of cases above will result in a statistical power (1-ß=0.2) of at least 80% to show a significant increase in performance of the full assay over clinical variables alone, assuming that performance characteristics are similar to those observed in a retrospective, independent training cohort and that the patients in the SAFELY cohort resemble this same training population.

Conditions

• Prostate Cancer Aggressiveness

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Subtraction Normalized Expression of Phagocytes Blood Test	Non-invasive blood based immunogenomic assay that targets RNA sequencing to identify disease and disease aggressiveness

Timeline

• Start date: 2019-09-09
• Primary completion: 2026-11-15
• Completion: 2029-09-30
• First posted: 2019-08-09
• Last updated: 2026-04-02

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study