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

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ClinicalTrials.gov Identifier: NCT03868579
Recruitment Status : Recruiting
First Posted : March 11, 2019
Last Update Posted : May 9, 2019
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Malignant Neoplasm Malignant Respiratory Tract Neoplasm Malignant Thoracic Neoplasm Procedure: Biopsy Other: Medical Chart Review Procedure: Thoracoscopy Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: A Pilot Study to Evaluate the Diagnostic Performance of Pleural Touch Preparations in Pleuroscopy, a Prospective Study
Actual Study Start Date : January 10, 2018
Estimated Primary Completion Date : June 30, 2019
Estimated Study Completion Date : June 30, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Biopsy

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 Name: Bx

Other: Medical Chart Review
Review medical chart
Other Name: Chart Review

Procedure: Thoracoscopy
Undergo pleuroscopy




Primary Outcome Measures :
  1. Specificity of rapid on site evaluation (ROSE) of touch preparations (preps) for predicting malignancy [ Time Frame: 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 :
  1. Sensitivity of ROSE of preps for predicting malignancy [ Time Frame: 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.

  2. Specificity of visual assessment of pleura for predicting malignancy [ Time Frame: 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.

  3. Sensitivity of visual assessment of pleura for predicting malignancy [ Time Frame: 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.

  4. Positive predictive value (PPV) for all patients [ Time Frame: 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.

  5. Negative predictive value (NPV) for all patients [ Time Frame: 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.

  6. Specificity of ROSE on touch preps between centers [ Time Frame: Up to 1 year ]
    Will be compared between centers using Chi-squared and Fisher exact tests.

  7. Sensitivity of ROSE on touch preps between centers [ Time Frame: Up to 1 year ]
    Will be compared between centers using Chi-squared and Fisher exact tests.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03868579


Contacts
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Contact: Horiana Grosu 713-792-6238 hbgrosu@mdanderson.org

Locations
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United States, Tennessee
Vanderbilt University/Ingram Cancer Center Recruiting
Nashville, Tennessee, United States, 37232
Contact: Fabien Maldonado    615-322-3412      
Principal Investigator: Fabien Maldonado         
United States, Texas
M D Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Horiana Grosu    713-792-6238      
Principal Investigator: Horiana Grosu         
Cyprus
Nicosia General Hospital Recruiting
Nicosia, Cyprus
Contact: Ilias Porfyridis       ilias_porfi@yahoo.gr   
Principal Investigator: Ilias Porfyridis         
Sponsors and Collaborators
M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Horiana Grosu M.D. Anderson Cancer Center

Additional Information:
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Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT03868579     History of Changes
Other Study ID Numbers: 2017-0746
NCI-2019-00735 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
2017-0746 ( Other Identifier: M D Anderson Cancer Center )
P30CA016672 ( U.S. NIH Grant/Contract )
First Posted: March 11, 2019    Key Record Dates
Last Update Posted: May 9, 2019
Last Verified: May 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Thoracic Neoplasms
Respiratory Tract Neoplasms
Neoplasms
Neoplasms by Site
Respiratory Tract Diseases