Targeted Biopsies and the Role of Cytological Imprints for Diagnosis of Prostate Cancer
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 2
- 主要终点
- The rate of positive and negative cytological imprints, e.g presence of malignant cells or not.
研究概览
简要总结
The investigators will evaluate the accuracy of performing cytological imprints of targeted biopsies when diagnosing prostate cancer.
It is useful to know whether the biopsy is cancer or not, in order to know when to stop sampling and when to continue.
The strategy is used in other types of cancer, e.g lung, breast etc
详细描述
Background:
When substituting a random biopsy procedure with a few targeted biopsies, it is of outmost importance to know immediately if the biopsy is positive or not. A recent study has demonstrated a high sensitivity and specificity of imprint cytology of random biopsies.
Aim:
The correlation between cytological imprints and histology of targeted prostate biopsies
Material&Method:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Prostate specific antigene (PSA) 4-20ng/ml, and/or abnormal digital rectal examination
- •No previous prostate biopsies
- •Positive MRI
- •Signed letter of informed concent
排除标准
- •Contraindications to MRI
- •Previous prostate biopsies
结局指标
主要结局
The rate of positive and negative cytological imprints, e.g presence of malignant cells or not.
时间窗: 15 months
The cytological imprints will be compared to the histology of targeted biopsies (defined as gold standard). Measure of agreement, sensitivity and specificity will be calculated.
次要结局
- Interobserver variability(15 months)