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A Pilot Study to Evaluate the Diagnostic Performance of Pleural Touch Preparations in Pleuroscopy, a Prospective Study
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.
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.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Mayo Clinic
Rochester, Minnesota, United States
Vanderbilt University/Ingram Cancer Center
Nashville, Tennessee, United States
M D Anderson Cancer Center
Houston, Texas, United States
Nicosia General Hospital
Nicosia, Cyprus
Start Date
January 10, 2018
Primary Completion Date
February 27, 2025
Completion Date
February 27, 2025
Last Updated
March 5, 2025
97
ACTUAL participants
Biopsy
PROCEDURE
Medical Chart Review
OTHER
Thoracoscopy
PROCEDURE
Lead Sponsor
M.D. Anderson Cancer Center
Collaborators
NCT00026884
NCT04585750
Data Source & Attribution
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