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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Malignant Neoplasm; Malignant Respiratory Tract Neoplasm; Malignant Thoracic Neoplasm
• Intervention / Treatment: Procedure: Biopsy; Other: Medical Chart Review; Procedure: Thoracoscopy

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 Type: Interventional
• Enrollment (Actual): 97
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Cyprus
  • Nicosia, Cyprus
    • Nicosia General Hospital
• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic
  • Tennessee
    • Nashville, Tennessee, United States, 37232
      • Vanderbilt University/Ingram Cancer Center
  • Texas
    • Houston, Texas, United States, 77030
      • M D Anderson Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patients who will undergo pleuroscopy with biopsy

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Observational (pleuroscopy, medical chart review); Patients undergo biopsy of the lining of the lung using pleuroscopy. Medical chart of patients is also reviewed.	Procedure: Biopsy; Undergo biopsy; Other Names: Bx; Other: Medical Chart Review; Review medical chart; Other Names: Chart Review; Procedure: Thoracoscopy; Undergo pleuroscopy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
Specificity of ROSE on touch preps between centers	Will be compared between centers using Chi-squared and Fisher exact tests.	Up to 1 year
Sensitivity of ROSE on touch preps between centers	Will be compared between centers using Chi-squared and Fisher exact tests.	Up to 1 year

Collaborators and Investigators

• Sponsor: M.D. Anderson Cancer Center
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Horiana Grosu, M.D. Anderson Cancer Center

Publications and helpful links

Helpful Links

• MD Anderson Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): January 10, 2018
• Primary Completion (Estimated): May 30, 2024
• Study Completion (Estimated): May 30, 2024

Study Registration Dates

• First Submitted: March 7, 2019
• First Submitted That Met QC Criteria: March 7, 2019
• First Posted (Actual): March 11, 2019

Study Record Updates

• Last Update Posted (Estimated): November 21, 2023
• Last Update Submitted That Met QC Criteria: November 17, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms by Site; Neoplasms; Thoracic Neoplasms; Respiratory Tract Neoplasms
• Other Study ID Numbers: 2017-0746 (Other Identifier: M D Anderson Cancer Center); NCI-2019-00735 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No