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Clinical Evaluation of ExoDx Prostate(IntelliScore) in Men Presenting for Initial Prostate Biopsy

NCT04720599 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 120

Last updated 2021-09-30

No results posted yet for this study

Summary

The study described here is being conducted to prospectively confirm the performance of the ExoDx Prostate gene expression assay in patients presenting for an initial prostate biopsy and support of CE-marking the test for a European Union Launch.

Conditions

  • Urologic Cancer

Interventions

DIAGNOSTIC_TEST

ExoDx Prostate(IntelliScore)

The ExoDx Prostate test result supports the biopsy decision process by stratifying patients based on risk for high grade prostate cancer

Sponsors & Collaborators

  • Exosome Diagnostics, Inc.

    lead INDUSTRY

Principal Investigators

  • Mikkel Noerholm · Exosome Diagnostics, Inc.

Eligibility

Min Age
50 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-06-01
Primary Completion
2021-06-01
Completion
2021-06-01

Countries

  • United States
  • Germany

Study Locations

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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 NCT04720599 on ClinicalTrials.gov