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NCT04720599

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

Completed Last updated 30 September 2021
What this trial tests

trial testing ExoDx Prostate(IntelliScore) in Urologic Cancer in 120 participants. Completed in 1 June 2021.

Timeline
1 June 2020
Primary endpoint
1 June 2021
1 June 2021

Quick facts

Lead sponsorExosome Diagnostics, Inc.
StatusCompleted
Study typeOBSERVATIONAL
Enrollment120
Start date1 June 2020
Primary completion1 June 2021
Estimated completion1 June 2021
Sites3 locations across United States, Germany

Drugs / interventions tested

Conditions studied

Sponsor

Exosome Diagnostics, Inc. — full company profile →

Who can join

50 and older, male only, with Urologic Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Immune Microenvironment in Osteosarcoma: Components, Therapeutic Strategies and Clinical Applications.
    Zhu T, Han J, Yang L, Cai Z, et al · · 2022 · cited 80× · PMID 35720360 · DOI 10.3389/fimmu.2022.907550
  2. Engineering therapeutical extracellular vesicles for clinical translation.
    Ma Y, Dong S, Grippin AJ, Teng L, et al · · 2025 · cited 58× · PMID 39227240 · DOI 10.1016/j.tibtech.2024.08.007
  3. Pre-diagnosis urine exosomal RNA (ExoDx EPI score) is associated with post-prostatectomy pathology outcome.
    Kretschmer A, Tutrone R, Alter J, Berg E, et al · · 2022 · cited 34× · PMID 35084544 · DOI 10.1007/s00345-022-03937-0
  4. Recent advances in conventional and unconventional vesicular secretion pathways in the tumor microenvironment.
    Kuo IY, Hsieh CH, Kuo WT, Chang CP, et al · · 2022 · cited 33× · PMID 35927755 · DOI 10.1186/s12929-022-00837-8
  5. Validation of a CE-IVD, urine exosomal RNA expression assay for risk assessment of prostate cancer prior to biopsy.
    Kretschmer A, Kajau H, Margolis E, Tutrone R, et al · · 2022 · cited 30× · PMID 35314720 · DOI 10.1038/s41598-022-08608-z
  6. Cancer-derived small extracellular vesicles: emerging biomarkers and therapies for pancreatic ductal adenocarcinoma diagnosis/prognosis and treatment.
    Zhang W, Campbell DH, Walsh BJ, Packer NH, et al · · 2022 · cited 29× · PMID 36242076 · DOI 10.1186/s12951-022-01641-0
  7. Exosomes: Insights and therapeutic applications in cancer.
    Panigrahi AR, Srinivas L, Panda J. · · 2022 · cited 27× · PMID 35551002 · DOI 10.1016/j.tranon.2022.101439
  8. Extracellular Vesicles for Clinical Diagnostics: From Bulk Measurements to Single-Vesicle Analysis.
    Tran HL, Zheng W, Issadore DA, Im H, et al · · 2025 · cited 25× · PMID 40720603 · DOI 10.1021/acsnano.5c00706

Verify or expand the search:

Other recruiting trials for Urologic Cancer

Currently open trials in the same condition.

Other Exosome Diagnostics, Inc. trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

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