Derivation and Validation of a Scoring System to Distinguish Cryptococcosis and Adenocarcinoma in Pulmonary Nodules

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Cryptococcosis, Lung Adenocarcinoma

Intervention / Treatment
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* Diagnostic Test: A scoring system


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with pulmonary nodules Evidence of pathological diagnosis for cryptococcosis or adenocarcinoma Data on high-resolution computed tomography (HRCT) Exclusion Criteria: Pulmonary nodules greater than 3cm in maximum diameter Lack of data on HRCT
Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cohort 1<br>Derivation Cohort of a Scoring System to Distinguish Cryptococcosis and Adenocarcinoma in Pulmonary Nodules | |
| Cohort 2<br>One of Validation Cohorts of a Scoring System to Distinguish Cryptococcosis and Adenocarcinoma in Pulmonary Nodules | Diagnostic Test: A scoring system<br>* The scoring system was used to rate score patients.<br>|
| Cohort 3<br>One of Validation Cohorts of a Scoring System to Distinguish Cryptococcosis and Adenocarcinoma in Pulmonary Nodules | Diagnostic Test: A scoring system<br>* The scoring system was used to rate score patients.<br>|
| Cohort 4<br>One of Validation Cohorts of a Scoring System to Distinguish Cryptococcosis and Adenocarcinoma in Pulmonary Nodules | Diagnostic Test: A scoring system<br>* The scoring system was used to rate score patients.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under receiver operating characteristic curve | Area under Receiver Operating Characteristic (ROC) curve was used to identify the diagnostic value of the scoring system. | up to 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity of the scoring system | Sensitivity of the scoring system was used to assess the true positive rate of pulmonary cryptococcosis | up to 24 weeks | 
| Specificity of the scoring system | Specificity of the scoring system was used to assess the true negative rate of pulmonary cryptococcosis | up to 24 weeks |