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

Lung Adenocarcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04554875
• Other study ID #: 20200410
• Status: Recruiting
• Start date: January 1, 2019
• Est. completion date: July 1, 2021

Study information

• Verified date: September 2020
• Source: Shanghai Pulmonary Hospital, Shanghai, China
• Contact: Jin-fu Xu, MD
• Phone: +86 13321922898
• Email: jfxucn[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: July 1, 2021
• Est. primary completion date: June 1, 2021
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Adenocarcinoma
• Adenocarcinoma of Lung
• Cryptococcosis
• Lung Adenocarcinoma
• Multiple Pulmonary Nodules

Intervention

Diagnostic Test:
• A scoring system
The scoring system was used to rate score patients.

Locations

Country	Name	City	State
China	Shanghai pulmonary hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Pulmonary Hospital, Shanghai, China

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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