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

Malignant Neoplasm Clinical Trial

Official title:

A Pilot Study to Evaluate the Diagnostic Performance of Pleural Touch Preparations in Pleuroscopy, a Prospective Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03868579
• Other study ID #: 2017-0746
• Secondary ID: NCI-2019-0073520
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 10, 2018
• Est. completion date: May 30, 2026

Study information

• Verified date: May 2024
• Source: M.D. Anderson Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 97
• Est. completion date: May 30, 2026
• Est. primary completion date: May 30, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients who will undergo pleuroscopy with biopsy

Exclusion Criteria:

• Patients with known malignant pleural effusion

• Inability or unwillingness to give informed consent

Related Conditions & MeSH terms

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

Intervention

Procedure:
• Biopsy
Undergo biopsy

Other:
• Medical Chart Review
Review medical chart

Procedure:
• Thoracoscopy
Undergo pleuroscopy

Locations

Country	Name	City	State
Cyprus	Nicosia General Hospital	Nicosia
United States	M D Anderson Cancer Center	Houston	Texas
United States	Vanderbilt University/Ingram Cancer Center	Nashville	Tennessee
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center	National Cancer Institute (NCI)

Countries where clinical trial is conducted

United States,  Cyprus, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Specificity of rapid on site evaluation (ROSE) of touch preparations (preps) for predicting malignancy	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.	Up to 1 year
Secondary	Sensitivity of ROSE of preps for predicting malignancy	Descriptive statistics (e.g., frequencies, ranges, means, medians, proportions, and SDs) along with 95% CIs for the means or proportions will be computed for the measures of interest. Sensitivity will be defined as true positive (TP) divided by (TP + false negative [FN]). 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.	Up to 1 year
Secondary	Specificity of visual assessment of pleura for predicting malignancy	Descriptive statistics (e.g., frequencies, ranges, means, medians, proportions, and SDs) along with 95% CIs for the means or proportions will be computed for the measures of interest. Specificity will be defined as TN divided by (TN + FP). High probability of malignancy is defined as presence of abnormalities, such as studding, presence of parietal or visceral masses or nodules, or abnormal tissue deposits consistent with malignancy. Low probability is defined as absence of abnormalities or presence of purulent, fibrino-purulent pleural fluid or parietal and/or visceral pleura inflammation or thickening. Indeterminate probability is defined as findings which cannot include or exclude malignancy with certainty, such as inflammation of the pleura or adhesions, but that cannot be classified by the interventionist in any of the above categories. Will collapse the indeterminate probability of malignancy on visual assessment into low probability for malignancy.	Up to 1 year
Secondary	Sensitivity of visual assessment of pleura for predicting malignancy	Descriptive statistics (e.g., frequencies, ranges, means, medians, proportions, and SDs) along with 95% CIs for the means or proportions will be computed for the measures of interest. Sensitivity will be defined as TP divided by (TP + FN). High probability of malignancy is defined as presence of abnormalities, such as studding, presence of parietal or visceral masses or nodules, or abnormal tissue deposits consistent with malignancy. Low probability is defined as absence of abnormalities or presence of purulent, fibrino-purulent pleural fluid or parietal and/or visceral pleura inflammation or thickening. Indeterminate probability is defined as findings which cannot include or exclude malignancy with certainty, such as inflammation of the pleura or adhesions, but that cannot be classified by the interventionist in any of the above categories. Will collapse the indeterminate probability of malignancy on visual assessment into low probability for malignancy.	Up to 1 year
Secondary	Positive predictive value (PPV) for all patients	PPV will be defined as TP divided by (TP + FP). Pre-test odds will be calculated using the formula: pre-test probability divided by (1 - pre-test probability). Post-test odds will be calculated using the formula: pre-test odds times likelihood ratio, and post-test probability was calculated using the formula: post-test odds divided by (1 + post-test odds). Likelihood ratios (LRs) will also be calculated by dividing the probability of a result in patients with the disease by the probability of the same result in patients without the disease.	Up to 1 year
Secondary	Negative predictive value (NPV) for all patients	NPV will be defined as TN divided by (TN + FN). Pre-test odds will be calculated using the formula: pre-test probability divided by (1 - pre-test probability). Post-test odds will be calculated using the formula: pre-test odds times likelihood ratio, and post-test probability was calculated using the formula: post-test odds divided by (1 + post-test odds). LRs will also be calculated by dividing the probability of a result in patients with the disease by the probability of the same result in patients without the disease.	Up to 1 year
Secondary	Specificity of ROSE on touch preps between centers	Will be compared between centers using Chi-squared and Fisher exact tests.	Up to 1 year
Secondary	Sensitivity of ROSE on touch preps between centers	Will be compared between centers using Chi-squared and Fisher exact tests.	Up to 1 year

External Links

•   MD Anderson Cancer Center