Rapid On Site Evaluation of Pleural Touch Preparations in Diagnosing Malignant Pleural Effusion in Patients Undergoing Pleuroscopy
NCT ID: NCT03868579
Last Updated: 2025-03-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
97 participants
INTERVENTIONAL
2018-01-10
2025-02-27
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
OTHER
NONE
Study Groups
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Observational (pleuroscopy, medical chart review)
Patients undergo biopsy of the lining of the lung using pleuroscopy. Medical chart of patients is also reviewed.
Biopsy
Undergo biopsy
Medical Chart Review
Review medical chart
Thoracoscopy
Undergo pleuroscopy
Interventions
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Biopsy
Undergo biopsy
Medical Chart Review
Review medical chart
Thoracoscopy
Undergo pleuroscopy
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Inability or unwillingness to give informed consent
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
M.D. Anderson Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Horiana Grosu
Role: PRINCIPAL_INVESTIGATOR
M.D. Anderson Cancer Center
Locations
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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
Countries
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Provided Documents
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Document Type: Informed Consent Form
Related Links
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MD Anderson Cancer Center
Other Identifiers
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NCI-2019-00735
Identifier Type: REGISTRY
Identifier Source: secondary_id
2017-0746
Identifier Type: OTHER
Identifier Source: secondary_id
2017-0746
Identifier Type: -
Identifier Source: org_study_id
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