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临床试验/NCT03893929
NCT03893929招募中不适用

The Investigation of New Biological Markers for Prostate Cancer Diagnosis and Management in Chinese Population

Chinese University of Hong Kong1 个研究点 分布在 1 个国家目标入组 5,000 人开始时间: 2015年10月7日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
5,000
试验地点
1
主要终点
To identify potential new urine markers for prognosis prediction for prostate cancer in Chinese population.

研究概览

简要总结

Prostate cancer (PC) is highly prevalent worldwide and is currently the 3rd most commonly diagnosed prostate cancer in Hong Kong male population with more than 1600 new cases diagnosed per year. However, the current use of serum PSA as a diagnostic marker is unsatisfactory. Many patients has elevated serum PSA is actually due to other causes and also the level of serum PSA do not correlate with the staging and grading of prostate cancer. Moreover, the current risk stratification system, based on PSA, clinical staging and Gleason score is of only limited value, as a significant proportion of patients with high-risk nonmetastatic PC have incurable disease due to locally advanced and/or occult metastasis,, whilst others with indolent disease may never suffer morbidity or mortality from PC.

Therefore, in order to improve patient management and outcome, there is a need to identify newer markers and also validate some potential markers in Chinese population.

详细描述

Prostate cancer (PC) is highly prevalent worldwide and is currently the 3rd most commonly diagnosed prostate cancer in Hong Kong male population with more than 1600 new cases diagnosed per year. Even with widely used serum Prostate Specific Antigen (PSA) diagnostic testing, more than 50% men with newly diagnosed PC are deemed to have highrisk disease. 1 However, the current use of serum PSA as a diagnostic marker is unsatisfactory. Many patients has elevated serum PSA is actually due to other causes and also the level of serum PSA do not correlate with the staging and grading of prostate cancer. 2 Moreover, the current risk stratification system, based on PSA, clinical staging and Gleason score is of only limited value, as a significant proportion of patients with high-risk nonmetastatic PC have incurable disease due to locally advanced and/or occult metastasis, whilst others with indolent disease may never suffer morbidity or mortality from PC. Furthermore, high-risk (non-metastatic) prostate cancer (thus defined) exhibits a high degree of heterogeneity of response to current treatment protocols. Lastly, the characteristics of prostate cancer in our Chinese population might not be the same as those in Caucasian. 3,4 Several single biomarkers have been introduced in an attempt to address the clinical need for better prognostic tests in prostate cancer. For example, increased pre-operative PSA velocity (≥2ng/ml/per year) has been associated with increased risk of recurrence after prostatectomy5 and mortality6, as have increased serum levels of Kallikrein-2 and [-2]-pro PSA.7-10 Pre-operative levels of prostate cancer gene 3 (PCA3) have been found to be elevated in tumours >0.5cc, 11 however these findings could not be confirmed in recent work.12 Therefore, in order to improve patient management and outcome, there is therefore an urgent need to improve our ability to identify newer markers and also validate some potential markers in our population.

研究设计

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

入排标准

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

入选标准

  • Adult Chinese male patients with age > 18 years old
  • Clinical suspected to have prostate cancer, based on abnormal digital rectal examination or elevated serum PSA level

排除标准

  • Patient refused or unable to provide consent for the study

结局指标

主要结局

To identify potential new urine markers for prognosis prediction for prostate cancer in Chinese population.

时间窗: Baseline (One-time point)

The role of urine spermine in the prognosis of prostate cancer

To identify potential new urine markers for the diagnosis for prostate cancer in Chinese population.

时间窗: Baseline (One-time point)

The role of urine spermine in the diagnosis of prostate cancer

To identify potential new blood markers for prognosis prediction for prostate cancer in Chinese population.

时间窗: Baseline (One-time point)

The application of Kallikrein-2 and \[-2\]-pro PSA in the prognosis of prostate cancer in Chinese population.

To identify potential new blood markers for the diagnosis for prostate cancer in Chinese population.

时间窗: Baseline (One-time point)

The application of Kallikrein-2 and \[-2\]-pro PSA in the diagnosis of prostate cancer in Chinese population.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

NG Chi Fai

Professor

Chinese University of Hong Kong

研究点 (1)

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