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临床试验/NCT04554875
NCT04554875Unknown不适用

Derivation and Validation of a Scoring System to Distinguish Cryptococcosis and Adenocarcinoma in Pulmonary Nodules: a Multicenter Observational Study.

Shanghai Pulmonary Hospital, Shanghai, China1 个研究点 分布在 1 个国家目标入组 1,000 人开始时间: 2019年1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
1,000
试验地点
1
主要终点
Area under receiver operating characteristic curve

研究概览

简要总结

Pulmonary cryptococcosis often manifests as isolated or multiple nodules, easily mimicking lung cancer clinically and radiologically, which ascribes the poor sensitivity of Cryptococcus culture and rarely positive of Cryptococcal antigen test in the absence of disseminated disease. Therefore, the aim of this study was to develop a predictive scoring system from the perspective of available clinical indicators, to differentiate cryptococcosis from adenocarcinoma in pulmonary nodules, which might be beneficial for the delicacy management of pulmonary nodules.

详细描述

Nodule is generally defined as a small, approximately spherical in morphology, circumscribed focus of abnormal tissue on computed tomography (CT) and no greater than 3cm in maximum diameter. Pulmonary nodules are not uncommon. A systematic review of CT screening lung cancer trials noted that a lung nodule was detected in up to 51% of study participants. More than 95% of detected nodules are benign and have a wide variety of causes, including infections, granulomatous disease, hamartomas, arteriovenous malformations, round atelectasis, and lymph nodes.

Pulmonary cryptococcosis is caused by Cryptococcus spp., a ubiquitous budding yeast-like basidiomycete that is endemic in many countries. Previously, Pulmonary cryptococcosis was thought to be an important opportunistic invasive mycosis in immunocompromised patients, such as AIDS, immunosuppressor used after organ transplantation, but it is also common in immunocompetent patients. Pulmonary cryptococcosis often manifests as isolated or multiple nodules, easily mimicking lung cancer clinically and radiologically, which ascribes the poor sensitivity of Cryptococcus culture and rarely positive of Cryptococcal antigen test in the absence of disseminated disease.

Therefore, the aim of this multicenter observational study was to develop a predictive scoring system from the perspective of available clinical indicators, to differentiate cryptococcosis from adenocarcinoma in pulmonary nodules, which might be beneficial for the delicacy management of pulmonary nodules.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Retrospective

入排标准

性别
All
接受健康志愿者

入选标准

  • Patients with pulmonary nodules
  • Evidence of pathological diagnosis for cryptococcosis or adenocarcinoma
  • Data on high-resolution computed tomography (HRCT)

排除标准

  • Pulmonary nodules greater than 3cm in maximum diameter
  • Lack of data on HRCT

结局指标

主要结局

Area under receiver operating characteristic curve

时间窗: up to 24 weeks

Area under Receiver Operating Characteristic (ROC) curve was used to identify the diagnostic value of the scoring system.

次要结局

  • Sensitivity of the scoring system(up to 24 weeks)
  • Specificity of the scoring system(up to 24 weeks)

研究者

发起方
Shanghai Pulmonary Hospital, Shanghai, China
申办方类型
Other
责任方
Principal Investigator
主要研究者

Jin-Fu Xu

Professor

Shanghai Pulmonary Hospital, Shanghai, China

研究点 (1)

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