Learning Curve of Digital Rectal Examination for Prostate Cancer Among Internship
试验速览
- 阶段
- 不适用
- 入组人数
- 700
- 试验地点
- 1
- 主要终点
- Sensitivity and specificity of DRE performed by internship will be confirmed by prostate biopsy
研究概览
简要总结
The investigators conduct this prospective study to investigate the learning curve of digital rectal examination (DRE) for prostate cancer among internship. The investigators want to know how many DRE are usually needed for internship to be performed in urological practice to obtain a stable DRE accuracy.
详细描述
Digital rectal examination (DRE) is a basic physical examination in routine practice in Urology. The DRE is a very important daily practice for screen prostate cancer, and each internship in Urology is required to perform this for patients suspected of prostate cancer or benign prostate hyperplasia. However, how many DRE are usually needed for a internship to perform so as to obtain a stable accuracy in daily practice is currently unknown. The investigators thus conduct this prospective trial to investigate the learning curve of DRE among internship.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Internship just graduate from the medical school, and agree to attend the study.
- •Internship have less than 5 DREs of prostate cancer.
- •Patients of any age who are included for prostate biopsy are eligible, the indications for prostate biopsy are as follows: PSA>4ng/ml, fPSA/tPSA<0.16, with suspected palpable nodes in the prostate by DRE of attending doctor, suspected mass in prostate detected by ultrasound examination, magnetic resonance imaging, or computed tomography.
排除标准
- •Internship who are not willing to attend the study.
- •Internship stop doing DRE for continuously 3 months after entering the study.
结局指标
主要结局
Sensitivity and specificity of DRE performed by internship will be confirmed by prostate biopsy
时间窗: One year
To examine the sensitivity and specificity of the DRE performed by internship to reference standard of prostate biopsy in a prospective longitudinal cohort of around 700 participants who will undergo prostate biopsy due to suspect of prostate cancer. The investigators will investigate the sensitivity and specificity of DRE by different internship monthly.
次要结局
- Sensitivity and specificity of DRE performed by internship with different training plan will be confirmed by prostate biopsy(One year)
- Sensitivity and specificity of DRE performed by internship will be compared to the results of fPSA/tPSA and MRI.(One year)
研究者
Zeng Shuxiong
Attending doctor in the Department of urology
Changhai Hospital