Clinical trial · Interventional
Rapid On Site Evaluation of Pleural Touch Preparations in Diagnosing Malignant Pleural Effusion in Patients Undergoing Pleuroscopy
A Pilot Study to Evaluate the Diagnostic Performance of Pleural Touch Preparations in Pleuroscopy, a Prospective Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This trial studies how well rapid on site evaluation of pleural touch preparations works in diagnosing cancerous fluid in between the linings of the lungs (malignant pleural effusion) in patients undergoing a pleuroscopy. A type of laboratory testing called rapid on site evaluation of pleural touch preparations that uses pleural biopsy tissue samples collected during an already-scheduled pleuroscopy may be able to diagnose malignant pleural effusion.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Malignant Neoplasm | Malignant Neoplasm | ONTOLOGY_EXACT | 0.90 |
| Malignant Respiratory Tract Neoplasm | Malignant Respiratory System Neoplasm | ALIAS | 0.90 |
| Malignant Thoracic Neoplasm | Malignant Thoracic Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Biopsy | Procedure | — | UNRESOLVED |
| Medical Chart Review | Other | — | UNRESOLVED |
| Thoracoscopy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Observational (pleuroscopy, medical chart review)
- description
- Patients undergo biopsy of the lining of the lung using pleuroscopy. Medical chart of patients is also reviewed.
- interventionNames
- Procedure: Biopsy
- Other: Medical Chart Review
- Procedure: Thoracoscopy
Primary outcomes (1)
- measure
- Specificity of rapid on site evaluation (ROSE) of touch preparations (preps) for predicting malignancy
- timeFrame
- Up to 1 year
- description
- Descriptive statistics (e.g., frequencies, ranges, means, medians, proportions, and standard deviations \[SDs\]) along with 95% confidence intervals (CIs) for the means or proportions will be computed for the measures of interest. Specificity will be defined as true negative (TN) divided by (TN + false positive \[FP\]). High probability of malignancy is defined as adequate tissue with tumor present. Low probability of malignancy defined is adequate tissue with no tumor present. Indeterminate probability of malignancy is defined as presence of atypical cells but inadequate for a definitive diagnosis on ROSE. Will collapse the indeterminate probability of malignancy (atypical cells category) found on touch preps into low probability for malignancy bin and indeterminate probability of malignancy on visual assessment into low probability for malignancy.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients who will undergo pleuroscopy with biopsy Exclusion Criteria: * Patients with known malignant pleural effusion * Inability or unwillingness to give informed consent
References
Publications (0)
Data not yet available