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Identification of Clinically Insignificant or Significant Prostate Cancer With the miR Scientific Sentinel™ Platform

NCT04100811 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 2019

Last updated 2023-10-25

No results posted yet for this study

Summary

In this non-interventional study, men being seen by urologists in the course of their normal practice that present with clinical suspicion of prostate cancer (based on DRE, elevated Prostate Specific Antigen (PSA), and/or family medical history of prostate cancer, among other reasons) and who meet the inclusion/exclusion criteria will be asked to consent to the clinical study and provide a 40-60 mL urine sample, without prior DRE, along with relevant de-identified clinical data, at the time of the initial consultation, prior to core-needle biopsy.

The miR Scientific Sentinel® Prostate Cancer Classifier Platform (Sentinel® PCC4 Test) is a new molecular test that interrogates 442 small non-coding RNAs (sncRNA) extracted from urinary exosomes. Using the expression levels of 442 sncRNAs isolated from urine exosomes, the Sentinel® PCC4 Test provides an initial classification of disease status as either no molecular evidence of prostate cancer (NMEPC), or molecular evidence (MEPC) of low-, intermediate- or high-risk of aggressive prostate cancer. This study is designed to validate the classification algorithm and finalize the performance characteristics of the Test using risk-group labeling based on pathological grading from core-needle biopsy data.

Conditions

Sponsors & Collaborators

  • miR Scientific LLC

    lead INDUSTRY

Principal Investigators

  • Carl A Olsson, MD · Integrated Medical Professionals

Eligibility

Min Age
45 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-12-01
Primary Completion
2024-06-30
Completion
2024-12-31

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04100811 on ClinicalTrials.gov