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Clinical Trials in the USA / NCT04052048
Recruiting Observational

Active Surveillance SNEP Assay Registry Trial for Prostate Cancer

NCT04052048 · tracked via the Priya Life Science USA tracker
Sponsor
Immunis.AI
Phase
Observational
Started
2019-09-09
Last updated
2026-04-02

Condition(s) studied

Prostate Cancer Aggressiveness

Investigational drug(s) / intervention(s)

Subtraction Normalized Expression of Phagocytes Blood Test

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

Study summary

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

Eligibility

Sex
MALE
Min age
40 Years
Max age
80 Years
Healthy volunteers
No
Inclusion Criteria * Men between 40-80 of age with at least a 10-year life expectancy * All active surveillance protocols are accepted * No PSA limits Category 1: * Patient is currently on active surveillance with only ONE previous low grade prostate biopsy. * Patient must already be scheduled for their 1st annual biopsy under their active surveillance protocol within 90 days of enrollment date. Category 2: • Patient is recently diagnosed with low grade prostate cancer but has decided against active surveillance and is scheduled for radical prostatectomy within 90 days of enrollment date. Exclusion Criteria: Men on watchful waiting i.e. those with less than 10-year life expectancy with no intent for curative therapy * Men with symptoms or rising PSA who have not been proven to have cancer by tissue biopsy i.e. men with only negative prostate biopsies. * Patients with a history of a different cancer (except basal cell carcinoma)

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Comprehensive Urology Royal Oak Michigan Recruiting

More Immunis.AI trials in the USA

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04052048 on ClinicalTrials.gov ↗ ← All trials in the USA