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

Not Applicable

Active, not recruiting

• Conditions: Malignant Respiratory Tract Neoplasm; Malignant Thoracic Neoplasm; Malignant Neoplasm
• Interventions: Procedure: Biopsy; Other: Medical Chart Review; Procedure: Thoracoscopy

• Registration Number: NCT03868579
• Lead Sponsor: M.D. Anderson Cancer Center

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.

Study Timeline

• Study Start: 2018-01-10
• Study First Submitted: 2019-03-07
• Study First Submitted QC: 2019-03-07
• Study First Posted: 2019-03-11
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-19
• Last Update Posted: 2024-11-21
• Primary Completion: 2026-05-30
• Study Completion: 2026-05-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 97

Inclusion Criteria

• Patients who will undergo pleuroscopy with biopsy

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Observational (pleuroscopy, medical chart review)	Biopsy	Patients undergo biopsy of the lining of the lung using pleuroscopy. Medical chart of patients is also reviewed.
Observational (pleuroscopy, medical chart review)	Medical Chart Review	Patients undergo biopsy of the lining of the lung using pleuroscopy. Medical chart of patients is also reviewed.
Observational (pleuroscopy, medical chart review)	Thoracoscopy	Patients undergo biopsy of the lining of the lung using pleuroscopy. Medical chart of patients is also reviewed.

Primary Outcome Measures

Name	Time	Method
Specificity of rapid on site evaluation (ROSE) of touch preparations (preps) for predicting malignancy	Up to 1 year	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.

Secondary Outcome Measures

Name	Time	Method
Positive predictive value (PPV) for all patients	Up to 1 year	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.
Sensitivity of ROSE of preps for predicting malignancy	Up to 1 year	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.
Specificity of visual assessment of pleura for predicting malignancy	Up to 1 year	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.
Sensitivity of visual assessment of pleura for predicting malignancy	Up to 1 year	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.
Negative predictive value (NPV) for all patients	Up to 1 year	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.
Specificity of ROSE on touch preps between centers	Up to 1 year	Will be compared between centers using Chi-squared and Fisher exact tests.
Sensitivity of ROSE on touch preps between centers	Up to 1 year	Will be compared between centers using Chi-squared and Fisher exact tests.

Trial Locations

Locations (4)

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