Prostate Impendance Test Project (PROS.IT) in Prostate Cancer Diagnosis: a Cross-sectional Observational Study
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Impedance-based analysis based on phase-sensitive sensors
研究概览
简要总结
Impedance-based analysis could provide an adequate response to the need to identify a safe and reliable tool alternative to bioptic diagnosis. Patients who are candidates for prostate biopsy as suffering from urinary symptoms accompanied by clinical suspicions such as high total PSA value and / or presence of prostate nodule and / or evidence of obvious lesion to available imaging methods will be subjected to impedance measurement. Aim of this study is to be able to structure a bivariate analysis of the distribution of impedances detected in patients with neoplasia in order to detect test median reference values.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 45 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •age> 45 years
- •up of total PSA values beyond the normal range (> 4 ng / ml)
- •presence or absence of suspicious prostate nodule
排除标准
- •previous history of cancer
- •patients with previous diagnosis of PIN HG at prostate core biopsy or in active surveillance
结局指标
主要结局
Impedance-based analysis based on phase-sensitive sensors
时间窗: during rectal examination
次要结局
未报告次要终点
研究者
Prof. Riccardo Bartoletti
Prostate Impedance Test (PROS.iT) Project in prostate cancer diagnosis: a cross-sectional observational study
University of Pisa