NCT03868579

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 97 (actual)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

PRIMARY OBJECTIVES: I. To estimate the specificity of rapid on site evaluation (ROSE) of touch preparations (preps) for predicting malignancy on final pathology in pleuroscopy. SECONDARY OBJECTIVES: I. To estimate the sensitivity of rapid on site evaluation (ROSE) of touch preparations (preps) for predicting malignancy on final pathology in pleuroscopy. II. To estimate the specificity and sensitivity of visual assessment of pleura for predicting malignancy on final pathology in pleuroscopy. III. To compare the specificity and sensitivity of ROSE of touch preps between centers. OUTLINE: Patients undergo biopsy of the lining of the lung using pleuroscopy. Medical chart of patients is also reviewed.

Conditions

• Malignant Neoplasm
• Malignant Respiratory Tract Neoplasm
• Malignant Thoracic Neoplasm

Interventions

Type	Name	Description
PROCEDURE	Biopsy	Undergo biopsy
OTHER	Medical Chart Review	Review medical chart
PROCEDURE	Thoracoscopy	Undergo pleuroscopy

Timeline

• Start date: 2018-01-10
• Primary completion: 2025-02-27
• Completion: 2025-02-27
• First posted: 2019-03-11
• Last updated: 2025-03-05

Locations

4 sites across 2 countries: United States, Cyprus