Role of Rapid On-site Evaluation for Mutational Analysis of EBUS-TBNA Specimens
NCT ID: NCT01799382
Last Updated: 2014-10-07
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
126 participants
INTERVENTIONAL
2013-02-28
2014-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
DIAGNOSTIC
SINGLE
Study Groups
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EBUS-TBNA + Rapid on-site evaluation
Patients in this arm will undergo rapid-on site evaluation of samples obtained with EBUS-TBNA
Rapid on-site evaluation
Rapid on-site evaluation consists on the cytological evaluation of samples obtained during a diagnostic procedure by a pathologist present in the diagnostic suite. In the present study, cytological samples obtained with EBUS-TBNA during bronchoscopy will be evaluated.
EBUS-TBNA
EBUS-TBNA is a needle aspiration procedure guided by endobronchial ultrasounds performed during bronchoscopy
EBUS-TBNA
Patients in this arm will undergo EBUS-TBNA without rapid on-site evaluation
EBUS-TBNA
EBUS-TBNA is a needle aspiration procedure guided by endobronchial ultrasounds performed during bronchoscopy
Interventions
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Rapid on-site evaluation
Rapid on-site evaluation consists on the cytological evaluation of samples obtained during a diagnostic procedure by a pathologist present in the diagnostic suite. In the present study, cytological samples obtained with EBUS-TBNA during bronchoscopy will be evaluated.
EBUS-TBNA
EBUS-TBNA is a needle aspiration procedure guided by endobronchial ultrasounds performed during bronchoscopy
Eligibility Criteria
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Inclusion Criteria
* Suspected hilar or mediastinal lymph node metastasis from lung cancer
Exclusion Criteria
* Uncontrolled coagulopathy
* Refusal to sign informed consent
18 Years
85 Years
ALL
No
Sponsors
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Maggiore Bellaria Hospital, Bologna
OTHER
Responsible Party
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Rocco Trisolini
M.D.
Principal Investigators
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Rocco Trisolini, MD
Role: PRINCIPAL_INVESTIGATOR
Maggiore Hospital, Bologna, Italy
Locations
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Maggiore Hospital
Bologna, Emilia-Romagna, Italy
Countries
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References
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Trisolini R, Cancellieri A, Tinelli C, de Biase D, Valentini I, Casadei G, Paioli D, Ferrari F, Gordini G, Patelli M, Tallini G. Randomized Trial of Endobronchial Ultrasound-Guided Transbronchial Needle Aspiration With and Without Rapid On-site Evaluation for Lung Cancer Genotyping. Chest. 2015 Dec;148(6):1430-1437. doi: 10.1378/chest.15-0583.
Other Identifiers
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13001-Trisolini
Identifier Type: -
Identifier Source: org_study_id
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