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Validation of a Platelet Proteomic Assay for Diagnosing and Monitoring Prostate Cancer

Recruitingn/aAges 40 Years - anyMaleDuke University
NCT07144228 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

This is a single center study evaluating whether a new blood test based on platelet proteins rather than plasma proteins can improve detection of prostate cancer and evaluate the degree of serious disease. Currently, doctors rely on multiple tests such as PSA, MRI scans and biopsies to do the same evaluation. Researchers are trying to see if HeLP™ can be a safe and accurate alternative. The study is inviting men who are being seen for suspicion of prostate cancer (based on symptoms or previous lab results). If they agree to be in the study, the research team will take a sample of their blood at the time they are getting a repeat PSA test or having Imaging. The research test does not affect the care they are already receiving and takes 3 extra tubes of blood (\~3 tbsp). The research team is aiming to include 300 participants total. They believe 278 people are needed to confidently compa

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📋 Eligibility rules (as published)
Eligibility criteria * Patients ≥ 40 years of age * All patients with suspicion of PCa Men ≥ 40 years of age attending Duke Health/Urology with suspicion of prostate cancer (Primary disease) will be approached to consent for the study. Upon consent, samples will be obtained alone, during repeat PSA/other biomarkers testing, or during imaging at Duke Lab. Exclusion criteria * Men who have previously undergone treatment for prostate cancer. * Men with prior diagnosis of prostate cancer. * Men with severe, irreversible coagulopathy. * Men on anticoagulant therapies or those who have taken antiplatelet agents such as aspirin, NSAIDs (ibuprofen, entrophen, naproxen, diclofenac etc), clopidrogel, prasugrel, ticagrelor, or dipyridamole in the 7 days preceding blood collection.
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What it tests

  • HeLP TM
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Where

1 site
Duke University
Durham, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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