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临床试验/NCT05248282
NCT05248282Unknown不适用

A Single-Center, Retrospective, Blinded Validation Study to Investigate the Prognostic Value of the Prostatype Test System (PrTS) in Prostate Cancer Patients in China

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2021年9月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
150
试验地点
1
主要终点
prostate cancer-specific mortality

研究概览

简要总结

Prostate Cancer is the most common type of cancer among men in many countries. However current clinical tools have limited prediction accuracy to choose the optimal treatment for the individual patient, as prostate cancer risk assessment is a critical aspect of treatment decision-making. A substantial proportion of patients are undergoing over-treatment such as radical treatment, which is often associated with negative physical and psychological side effects, dramatically affecting quality of life in a negative way. Moreover, the patients that are under-treated will face higher cancer mortality risks, which brings more concerns for patients and doctors. Prostatype composes a one-step 4-plex quantitative reverse transcription polymerase chain reaction kit, a database based on authenic patients information and a score system (P-score), intended to measure gene expression levels of three biomarkers: IGFBP3, F3 and VGLL3. Genetic values combined with clinical parameters in the CPMA and P-score are aiming to estimate the aggressiveness of prostate tumor for a newly diagnosed prostate cancer patient. This is a single-center, retrospective, blinded validation study aim to investigate the prognostic performance of the Prostatype test system.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
50 Years 至 100 Years(Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

  • Non-metastatic prostate adenocarcinoma confirmed by histopathology after taking core needle biopsy
  • Regular visits, treatment and laboratory tests were conducted in the past
  • There is biopsy materials at the time of diagnosis (without staining FFPE)
  • The total area of tumor tissue shall be 25-30 mm2, and the proportion of tumor cells after tumor cell enrichment is at least 50%
  • Complete records of relevant clinical follow-up information

排除标准

  • Biopsy tissue is not available, or FFPE does not meet the screening requirements of study samples
  • Relevent clinical parameters of the patients are not available
  • Treatment methods are not available
  • Age of diagnosis < 50 years
  • Age of diagnosis > 100 years
  • Total tumor length < 2 mm
  • The patient died of an accident, homicide or suicide

结局指标

主要结局

prostate cancer-specific mortality

时间窗: up to 36 months

To verify that the prediction performance of risk stratification model (P-score) in the Chinese population is superior to that of the current European Society of Urology (EAU) risk stratification standard with regard to prostate cancer-specific mortality

次要结局

  • metastasis-free survival(up to 36 months)
  • Prognostic value of the three gene-signature in P-score(up to 36 months)

研究者

发起方
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
申办方类型
Other
责任方
Principal Investigator
主要研究者

Hongqian Guo

Director of Urology Department

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

研究点 (1)

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