Clinical trial NCT03868579: Rapid On Site Evaluation of Pleural Touch Preparations in Diagnosing Malignant Pleural Effusion in Patients Undergoing Pleuroscopy
Official title: A Pilot Study to Evaluate the Diagnostic Performance of Pleural Touch Preparations in Pleuroscopy, a Prospective Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Malignant Neoplasm
Malignant Respiratory Tract Neoplasm
Malignant Thoracic Neoplasm
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2019-03-11
Enrollment: 97
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief 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.

Eligibility criteria: Inclusion Criteria:

* Patients who will undergo pleuroscopy with biopsy

Exclusion Criteria:

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

Primary outcomes:
measure: Specificity of rapid on site evaluation (ROSE) of touch preparations (preps) for predicting malignancy
timeFrame: Up to 1 year
Secondary outcomes:
measure: Sensitivity of ROSE of preps for predicting malignancy
timeFrame: Up to 1 year
measure: Specificity of visual assessment of pleura for predicting malignancy
timeFrame: Up to 1 year
measure: Sensitivity of visual assessment of pleura for predicting malignancy
timeFrame: Up to 1 year
measure: Positive predictive value (PPV) for all patients
timeFrame: Up to 1 year
measure: Negative predictive value (NPV) for all patients
timeFrame: Up to 1 year
measure: Specificity of ROSE on touch preps between centers
timeFrame: Up to 1 year
measure: Sensitivity of ROSE on touch preps between centers
timeFrame: Up to 1 year
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Nashville
country: United States
facility: Vanderbilt University/Ingram Cancer Center
state: Tennessee
city: Houston
country: United States
facility: M D Anderson Cancer Center
state: Texas
city: Nicosia
country: Cyprus
facility: Nicosia General Hospital
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Horiana Grosu
role: PRINCIPAL_INVESTIGATOR
References: