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NCT04550416 · ClinicalTrials.gov registry record · NA
Effects of a New Diagnostic Test on the Care of Prostate Cancer Patients: The ProMark™ Clinical Utility Study
A NA study, sponsored by Qure Healthcare.
- Completed
- Registry status
- NA
- Development phase
- 217
- Enrollment target
NCT04550416 is a NA study that has completed, run by Qure Healthcare. The registered enrollment target is 217 participants.
The verdict
NCT04550416, a NA study, has completed, sponsored by Qure Healthcare.
- COMPLETED
- Registry status
- NA
- Development phase
- 217 participants
- Enrollment target
Study Summary
The objectives of this study are to assess clinical practice variation in prostate cancer diagnosis and treatment among urologists and how ProMark™ affects clinical practice decision-making. The study uses a randomized controlled study design of urologists. Urologists will be randomly assigned to a control and intervention arm. * Pre-intervention/baseline assessment: will be done using prostate cancer CPV® vignettes and a physician questionnaire to both control and intervention arms. * Intervention: 2-4 weeks after baseline introduce ProMark™ to the intervention group of urologists using a protocol to be determined by Metamark and QURE. * Post-intervention: 6 weeks post-intervention, a second round of prostate cancer CPV® vignettes will be administered to both control and intervention arms. The ProMark™ test will be available to "order" for all physicians taking the vignettes. The Clinical Performance and Value Vignettes (CPV®) used in this study simulate a clinical encounter for a man presenting with prostate cancer. Each urologist will provide responses to open-ended questions regarding clinical care they would provide for that patient. These responses are scored in five domains (taking a medical history, performing a physical examination, ordering appropriate tests, making a diagnosis and prescribing treatment against explicit evidence and criteria as determined by the literature and medical associations. Results are presented as percentage correct. Each case will take approximately 15-20 minutes to complete. All case responses will be completed online and kept confidential. The study hypotheses are: 1. Clinical practice, specifically decisions around prostate cancer treatment post-diagnosis, will vary widely among urologists. This variation in practice will demonstrate the need a new diagnostic, such as ProMark™, would fulfill. 2. ProMark™ will improve clinical decision making of urologists for prostate cancer patients with a Gleason Score of 3+3=6 and 3+4=7
Interventions
- OTHER ProMark Information and Test Results
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 217 participants |
| Start Date | 2014-05 |
| Est. Completion | 2015-01 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04550416
The ClinicalTrials.gov registry entry for NCT04550416 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 217 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Qure Healthcare, which has 21 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which ProMark Information and Test Results is the first listed.
NCT04550416 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04550416 about?
NCT04550416 is a clinical study titled "Effects of a New Diagnostic Test on the Care of Prostate Cancer Patients: The ProMark™ Clinical Utility Study". The objectives of this study are to assess clinical practice variation in prostate cancer diagnosis and treatment among urologists and how ProMark™ affects clinical practice decision-making. The study uses a randomized controlled study design of urologists. Urologists will be randomly assigned to a ...
What is the current status of trial NCT04550416?
This trial is currently completed. It is a NA study. The enrollment target is 217 participants. The study started on 2014-05. Estimated completion is 2015-01.
What interventions are being tested in trial NCT04550416?
The interventions under investigation include: ProMark Information and Test Results (OTHER).
Who is sponsoring clinical trial NCT04550416?
This trial is sponsored by Qure Healthcare, which has 21 total clinical trials registered on ClinicalTrials.gov.
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