Validation of a Platelet Proteomic Assay for Diagnosing and Monitoring Prostate Cancer: A Prospective Study.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Levels of HeLP™ proteins in the platelets of patients suspected to have PCa
研究概览
简要总结
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 compare results between people with and without prostate cancer.
They will do an interim analysis halfway through the study, once samples from 150 subjects have been collected.
The research is considered low risk-no more uncomfortable or dangerous than a blood draw. There is a risk of loss of privacy, but researchers are taking strong steps to protect privileged information. That includes proper data handling, secure, storage, and making sure the study team is trained in research ethics.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Control Group
Researchers are screening men who are suspicious of Pca, so those who will be negative for cancer will be the control group.
干预措施: HeLP TM (Device)
Case Group
Researchers are screening men who are suspicious of Pca, so those who will be diagnosed will be the case group.
干预措施: HeLP TM (Device)
结局指标
主要结局
Levels of HeLP™ proteins in the platelets of patients suspected to have PCa
时间窗: Baseline
Researchers will define the levels of HeLP™ proteins in the platelets of patients suspected to have PCa based on assessment within Duke Health compared to standard of care like PSA, mpMRI PI-RADS and other biomarkers (if available).
Diagnostic accuracy as reported by area under the curve (AUC)
时间窗: Baseline
Overall diagnostic accuracy of clinical variables including PSA, PI-RADS scoring, Hessian Map and other biomarkers (if available) will be determined and compared using receiving operating curve/area under curve analysis.
次要结局
未报告次要终点