Derivation and Validation of a Scoring System to Distinguish Cryptococcosis and Adenocarcinoma in Pulmonary Nodules
1 other identifier
observational
1,000
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2019
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2019
CompletedFirst Submitted
Initial submission to the registry
August 11, 2020
CompletedFirst Posted
Study publicly available on registry
September 18, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2021
CompletedSeptember 18, 2020
September 1, 2020
2.4 years
August 11, 2020
September 17, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
Sensitivity of the scoring system
up to 24 weeks
Specificity of the scoring system
up to 24 weeks
Study Arms (4)
Cohort 1
Derivation Cohort of a Scoring System to Distinguish Cryptococcosis and Adenocarcinoma in Pulmonary Nodules
Cohort 2
One of Validation Cohorts of a Scoring System to Distinguish Cryptococcosis and Adenocarcinoma in Pulmonary Nodules
Cohort 3
One of Validation Cohorts of a Scoring System to Distinguish Cryptococcosis and Adenocarcinoma in Pulmonary Nodules
Cohort 4
One of Validation Cohorts of a Scoring System to Distinguish Cryptococcosis and Adenocarcinoma in Pulmonary Nodules
Interventions
The scoring system was used to rate score patients.
Eligibility Criteria
Patients with pulmonary nodules, no greater than 3cm in maximum diameter, finally diagnosed with cryptococcosis or adenocarcinoma were included in this study.
You may qualify if:
- Patients with pulmonary nodules
- Evidence of pathological diagnosis for cryptococcosis or adenocarcinoma
- Data on high-resolution computed tomography (HRCT)
You may not qualify if:
- Pulmonary nodules greater than 3cm in maximum diameter
- Lack of data on HRCT
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Shanghai pulmonary hospital
Shanghai, Shanghai Municipality, 200433, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jin-fu Xu, MD
Shanghai Pulmonary Hospital, Shanghai, China
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
August 11, 2020
First Posted
September 18, 2020
Study Start
January 1, 2019
Primary Completion
June 1, 2021
Study Completion
July 1, 2021
Last Updated
September 18, 2020
Record last verified: 2020-09