A Pilot Study to Evaluate the Diagnostic Performance of Pleural Touch Preparations in Pleuroscopy, a Prospective Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 97
- 试验地点
- 4
- 主要终点
- Specificity of rapid on site evaluation (ROSE) of touch preparations (preps) for predicting malignancy
研究概览
简要总结
This trial studies how well rapid on site evaluation of pleural touch preparations works in diagnosing cancerous fluid in between the linings of the lungs (malignant pleural effusion) in patients undergoing a pleuroscopy. A type of laboratory testing called rapid on site evaluation of pleural touch preparations that uses pleural biopsy tissue samples collected during an already-scheduled pleuroscopy may be able to diagnose malignant pleural effusion.
详细描述
PRIMARY OBJECTIVES:
I. To estimate the specificity of rapid on site evaluation (ROSE) of touch preparations (preps) for predicting malignancy on final pathology in pleuroscopy.
SECONDARY OBJECTIVES:
I. To estimate the sensitivity of rapid on site evaluation (ROSE) of touch preparations (preps) for predicting malignancy on final pathology in pleuroscopy.
II. To estimate the specificity and sensitivity of visual assessment of pleura for predicting malignancy on final pathology in pleuroscopy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who will undergo pleuroscopy with biopsy
排除标准
- •Patients with known malignant pleural effusion
- •Inability or unwillingness to give informed consent
研究组 & 干预措施
Observational (pleuroscopy, medical chart review)
Patients undergo biopsy of the lining of the lung using pleuroscopy. Medical chart of patients is also reviewed.
干预措施: Biopsy (Procedure)
Observational (pleuroscopy, medical chart review)
Patients undergo biopsy of the lining of the lung using pleuroscopy. Medical chart of patients is also reviewed.
干预措施: Medical Chart Review (Other)
Observational (pleuroscopy, medical chart review)
Patients undergo biopsy of the lining of the lung using pleuroscopy. Medical chart of patients is also reviewed.
干预措施: Thoracoscopy (Procedure)
结局指标
主要结局
Specificity of rapid on site evaluation (ROSE) of touch preparations (preps) for predicting malignancy
时间窗: Up to 1 year
Descriptive statistics (e.g., frequencies, ranges, means, medians, proportions, and standard deviations \[SDs\]) along with 95% confidence intervals (CIs) for the means or proportions will be computed for the measures of interest. Specificity will be defined as true negative (TN) divided by (TN + false positive \[FP\]). High probability of malignancy is defined as adequate tissue with tumor present. Low probability of malignancy defined is adequate tissue with no tumor present. Indeterminate probability of malignancy is defined as presence of atypical cells but inadequate for a definitive diagnosis on ROSE. Will collapse the indeterminate probability of malignancy (atypical cells category) found on touch preps into low probability for malignancy bin and indeterminate probability of malignancy on visual assessment into low probability for malignancy.
次要结局
- Positive predictive value (PPV) for all patients(Up to 1 year)
- Sensitivity of ROSE of preps for predicting malignancy(Up to 1 year)
- Specificity of visual assessment of pleura for predicting malignancy(Up to 1 year)
- Sensitivity of visual assessment of pleura for predicting malignancy(Up to 1 year)
- Negative predictive value (NPV) for all patients(Up to 1 year)
- Specificity of ROSE on touch preps between centers(Up to 1 year)
- Sensitivity of ROSE on touch preps between centers(Up to 1 year)