Rapid On Site Evaluation of Pleural Touch Preparations in Diagnosing Malignant Pleural Effusion in Patients Undergoing Pleuroscopy

M.D. Anderson Cancer Center

Status: Completed

Conditions: Malignant Thoracic Neoplasm; Malignant Neoplasm; Malignant Respiratory Tract Neoplasm

Treatments: Other: Medical Chart Review; Procedure: Thoracoscopy; Procedure: Biopsy

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03868579

NCI-2019-00735 (Registry Identifier)

2017-0746 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 97 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients who will undergo pleuroscopy with biopsy

Exclusion criteria

• Patients with known malignant pleural effusion
• Inability or unwillingness to give informed consent

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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97 participants in 1 patient group

Observational (pleuroscopy, medical chart review)

Experimental group

Description:

Patients undergo biopsy of the lining of the lung using pleuroscopy. Medical chart of patients is also reviewed.

Treatment:

Procedure: Thoracoscopy

Procedure: Biopsy

Other: Medical Chart Review