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NCT03957252 · ClinicalTrials.gov registry record

Validation of ClarityDX Prostate as a Reflex Test to Refine the Prediction of Clinically-significant Prostate Cancer

A clinical trial of Prostate Cancer, sponsored by Nanostics.

Active
Registry status
2,800
Enrollment target
3
Study locations

NCT03957252: Active study of Prostate Cancer, sponsored by Nanostics.

NCT03957252 is a study of Prostate Cancer that is active but no longer recruiting, run by Nanostics. The registered enrollment target is 2,800 participants, above the 605-participant average among 735 other Prostate Cancer trials with a reported enrollment target (363% higher). The trial reports 3 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03957252, a study of Prostate Cancer, is active but no longer recruiting, sponsored by Nanostics.

ACTIVE NOT RECRUITING
Registry status
2,800 participants
Enrollment target
3
Study locations

Study Summary

This study is designed to determine the accuracy of blood test ClarityDX Prostate to predict the results of prostate biopsies in men who have PSA (Prostate Specific Antigen) greater or equal to 3 ng/mL.

Primary Outcome

Training Phase: Processed clinical features of each patient will be analyzed using machine learning to predict clinically significant prostate cancer, with the output being the ClarityDX Prostate Risk Score. Validation Phase: The models created during the Training Phase will be locked down and then used to determine the probability of approximately 1,400 patients in the investigational Validation Phase having clinically significant prostate cancer.

Conditions Studied

Interventions

  • DIAGNOSTIC_TEST Blood test: ClarityDX Prostate

Study Locations (3)

Alberta

  • Prostate Cancer Centre - Calgary
  • Kipnes Urology Centre - Edmonton

Maryland

  • Johns Hopkins University - Baltimore

Trial Details

FieldValue
Enrollment Target 2,800 participants
Start Date 2019-06-06
Est. Completion 2027-03
Nanostics

1 total trials

What the registry record for NCT03957252 still lists

NCT03957252 is an observational study that tracks outcomes without assigning an intervention. Its 2,800 participants enrollment target places it among the larger protocols in the corpus, above the 605-participant average among 735 other Prostate Cancer trials with a reported enrollment target (363% higher).

The record links to 1 condition, with Prostate Cancer appearing as the primary indexed condition, and to 1 intervention - of which Blood test: ClarityDX Prostate is the first listed.

NCT03957252 reports a single indexed study location in Alberta, Maryland.

Frequently Asked Questions

What is clinical trial NCT03957252 about?

NCT03957252 is a clinical study titled "Validation of ClarityDX Prostate as a Reflex Test to Refine the Prediction of Clinically-significant Prostate Cancer". This study is designed to determine the accuracy of blood test ClarityDX Prostate to predict the results of prostate biopsies in men who have PSA (Prostate Specific Antigen) greater or equal to 3 ng/mL.

What is the current status of trial NCT03957252?

This trial is currently active not recruiting. The enrollment target is 2,800 participants. The study started on 2019-06-06. Estimated completion is 2027-03.

What conditions does trial NCT03957252 study?

This clinical trial studies the following conditions: Prostate Cancer.

What interventions are being tested in trial NCT03957252?

The interventions under investigation include: Blood test: ClarityDX Prostate (DIAGNOSTIC_TEST).

Who is sponsoring clinical trial NCT03957252?

This trial is sponsored by Nanostics, which has 1 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03957252 being conducted?

This trial has 3 study locations across Maryland, Alberta. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Prostate Cancer

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT03957252's enrollment target sits among peer trials

2,800 20th of 735 higher than 716 of 735 other Prostate Cancer trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Prostate Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT03957252, the US trial registry maintained by the National Library of Medicine. NCT03957252 (large enrollment · single site footprint · active not recruiting) retrieved and formatted by PlainTrial, see methodology.