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Role of Rapid On-site Evaluation for Mutational Analysis of EBUS-TBNA Specimens

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01799382
Recruitment Status : Completed
First Posted : February 26, 2013
Last Update Posted : October 7, 2014
Sponsor:
Information provided by (Responsible Party):
Rocco Trisolini, Maggiore Bellaria Hospital, Bologna

Study Description
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Brief Summary:
The purpose of the study is to determine if rapid on-site evaluation of EBUS-TBNA samples can increase the percentage of patients with advanced non-squamous non-small cell lung cancer in whom both pathologic subtyping and mutational analysis are obtained.

Condition or disease Intervention/treatment Phase
Non-small Cell Lung Cancer Other: Rapid on-site evaluation Device: EBUS-TBNA Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 126 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Diagnostic
Official Title: Mutational Analysis of Endobronchial Ultrasound-guided Transbronchial Needle Aspiration (EBUS-TBNA) Specimens in Patients With Advanced Non-small Cell Lung Cancer: a Randomized Trial of Rapid On-site Evaluation
Study Start Date : February 2013
Actual Primary Completion Date : October 2014
Actual Study Completion Date : October 2014

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Arms and Interventions
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Arm Intervention/treatment
Experimental: EBUS-TBNA + Rapid on-site evaluation
Patients in this arm will undergo rapid-on site evaluation of samples obtained with EBUS-TBNA
 Other: 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.

Device: EBUS-TBNA
EBUS-TBNA is a needle aspiration procedure guided by endobronchial ultrasounds performed during bronchoscopy
Active Comparator: EBUS-TBNA
Patients in this arm will undergo EBUS-TBNA without rapid on-site evaluation
 Device: EBUS-TBNA
EBUS-TBNA is a needle aspiration procedure guided by endobronchial ultrasounds performed during bronchoscopy


Outcome Measures
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Primary Outcome Measures :
  1. Mutational analysis of epidermal growth factor receptor (EGFR), K-ras, and ALK (anaplastic lymphoma kinase) genes [ Time Frame: 18 months ]
    Percentage of patients for whom the mutational analysis of epidermal growth factor receptor (EGFR), K-ras, and ALK (anaplastic lymphoma kinase) genes on EBUS-TBNA samples is obtained


Secondary Outcome Measures :
  1. Diagnostic yield of EBUS-TBNA [ Time Frame: 18 months ]
  2. Adequacy of EBUS-TBNA samples [ Time Frame: 18 months ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age > 18 years
  • Suspected hilar or mediastinal lymph node metastasis from lung cancer

Exclusion Criteria:

  • Pregnancy
  • Uncontrolled coagulopathy
  • Refusal to sign informed consent
Contacts and Locations
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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): NCT01799382


Locations
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Italy
Maggiore Hospital
Bologna, Emilia Romagna, Italy, 40133
Sponsors and Collaborators
Maggiore Bellaria Hospital, Bologna
Investigators
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Principal Investigator: Rocco Trisolini, MD Maggiore Hospital, Bologna, Italy
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Rocco Trisolini, M.D., Maggiore Bellaria Hospital, Bologna
ClinicalTrials.gov Identifier: NCT01799382    
Other Study ID Numbers: 13001-Trisolini
First Posted: February 26, 2013    Key Record Dates
Last Update Posted: October 7, 2014
Last Verified: October 2014
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
 Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms