Serous cavity effusions
Conditions
Interventions
Gold Standard:The reference malignant diagnosis of a positive result prioritized histopathological specimens with positive findings, followed by cytological positive results including immunohistochemi
Index test:Rapid on-site evaluation (ROSE)
Sponsors
Beijing Jishuitan Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Hospitalized patients with drainable serous cavity effusions from whom a minimum of 60 ml of fluid can be collected to meet the requirements for both cytopathological analysis and rapid on-site evaluation (ROSE); 2. Patients aged 18 years or older, for whom informed consent has been obtained from either the participant or their legal surrogate; 3. The underlying cause of the serous cavity effusion must be definitively established within a follow-up period of two years.
Exclusion criteria
Exclusion criteria: Exclusion criteria has comprised insufficient effusion volume, inadequate cellularity, or unresolved diagnoses within a follow-up period of two years.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Area under the curve between Rapid On-Site Evaluation and Conventional Cytopathology for malignant diagnosis; | — |
Secondary
| Measure | Time frame |
|---|---|
| Sensitivity between Rapid On-Site Evaluation and Conventional Cytopathology for malignant diagnosis;Specificity between Rapid On-Site Evaluation and Conventional Cytopathology for malignant diagnosis;Area under the curve of the ROSE-CC integration for malignant diagnosis;Sensitivity among various tumor subtypes by ROSE;Area under the curve between Rapid On-Site Evaluation and Conventional Cytopathology for bacterial infection;Area under the curve between Rapid On-Site Evaluation and Conventional Cytopathology for tuberculosis infection;Area under the curve between Rapid On-Site Evaluation and Conventional Cytopathology for effusions due to cardiac failure or renal failure or liver cirrhosis;Area under the curve between Rapid On-Site Evaluation and Conventional Cytopathology for effusions due to autoimmune diseases; | — |
Countries
China
Contacts
Public ContactLing Luo
Beijing Jishuitan Hospital affiliated to Capital Medical University
Outcome results
None listed