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临床试验/NCT04251546
NCT04251546Unknown不适用

Prediction Model fo Screening and Diagnosis of Prostate Cancer in PSA Gray Zone Based on Serum PHI Combined With TPV

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2020年1月4日最近更新:
适应症

试验速览

阶段
不适用
入组人数
80
试验地点
1
主要终点
Pathological confirmed diagnosis of prostate cancer or benign prostatic diseases

研究概览

简要总结

Prostate cancer (PCa) is a high incidence tumor of elderly men. In recent years, its incidence has rapidly increased in China. Serological examination of prostate-specific antigen (PSA) is particularly important in the early diagnosis of PCa, but its specificity is lower in gray areas with PSA between 4-10 ng / ml. Proposition of prostate health index (PHI) strengthens the specificity of PSA gray area prostate cancer diagnosis, but the composition of the index only relies on serological examination, neglects imaging indicators, and cannot be comprehensively evaluated. Based on the preliminary basis of PHI research in the undergraduate department, combined with ultrasound imaging indicators of total prostate volume (TPV), this research group prospectively analyzed the efficacy of PHI combined with TPV to predict prostate cancer in patients with PSA gray areas, and established an improved version of PHI-TPV combination. The prediction model mPHI assesses the sensitivity of the new model to predict the risk of prostate cancer in the Chinese population, provides data support for puncture decisions of middle-aged and elderly male patients in the gray area of PSA in China, and provides reference and guidance for the individualized prevention and treatment of prostate cancer.

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
45 Years 至 —(Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

  • Patient> 45 years of age
  • Abnormal serum PSA
  • Prostate nodules found by DRE
  • Abnormal MRI or TRUS finding

排除标准

  • Incomplete medical history
  • Poor quality of serum samples
  • Bacterial acute prostatitis diagnosed within 3 months before biopsy 4.5α reductase inhibitors, anabolic steroids, or antiandrogen drugs taken within 12 months before biopsy
  • 5.Previous prostate biopsy history.

结局指标

主要结局

Pathological confirmed diagnosis of prostate cancer or benign prostatic diseases

时间窗: 2019/05/01-2021/05/30

Pathological confirmed diagnosis by transrectal ultrasound guided prostate biopsy (12 needles) according to a standardized protocol. If a suspicious low-density nodule is found during the ultrasound, biopsy to the nodule can be added. Place the prostate biopsy specimen in a 10% Formalin's specimen bag. The specimens were processed and evaluated by the Pathology Department of Xinhua Hospital.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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