跳至主要内容
临床试验/NCT03270228
NCT03270228已完成不适用

Natural History of Nonspecific Pleuritis Diagnosed After Video-assisted-thoracoscopic-surgery

Naestved Hospital1 个研究点 分布在 1 个国家目标入组 10,000 人开始时间: 2017年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
10,000
试验地点
1
主要终点
Incidence of cancer

研究概览

简要总结

The investigators want to determine the incidence of malignant disease, type of malignant disease and overall survival in patients diagnosed with NSP after VATS.

详细描述

Using Landspatientregisteret (LPR) (the National Patient register) the investigators will identify patients who have received a thoracoscopic pleural-biopsy using the SKS-codes KGAC01 and/or KGAA31 and/or KGAC00. From LPR and Cancerregisteret (the National Cancer-register) the investigators will receive diagnosis and additional descriptive data. From dødsårsagsregisteret (the National cause-of-death-register) death date and further descriptive data will be acquired.

Patients with NSP will be identified as patients with no diagnosis six months after pleural-biopsy, despite a thorough investigation.

Patients with a malignant effusion and non-malignant effusion (with known cause) will be used for survival analysis and comparison.

Data Data will be registered in the individual patients CRF (Case Report File) (digital) and will be transferred to a database-program for further processing. Background-variables will be used to describe the study population. Only study-coordinators will have access to data. All data including back-up will be stored and kept in a locked cupboard in a locked room. Only study coordinators possess relevant keys.

Statistics The investigators define significance level (α) as 0.05, and power (β) as 0.80. Descriptive data will be analysed using nonparametric statistics: Chi2-test for categorical data and Mann-Whitney for discrete data. Statistical significance is defined as: p-value < 0.05.

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
16 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • All patients with a VATS thoracoscopy

排除标准

  • 未提供

结局指标

主要结局

Incidence of cancer

时间窗: 10 years

Percentage

次要结局

  • Type of cancer(10 years)
  • Survival of patients(10 years)

研究者

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

Simon Reuter

Ph.d.-Student

Naestved Hospital

研究点 (1)

Loading locations...

相似试验