Role of Rapid On-site Evaluation for Mutational Analysis of EBUS-TBNA Specimens
October 5, 2014 updated by: Rocco Trisolini, Maggiore Bellaria Hospital, Bologna
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
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
126
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Emilia Romagna
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Bologna, Emilia Romagna, Italy, 40133
- Maggiore Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 85 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / 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
|
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 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
|
EBUS-TBNA is a needle aspiration procedure guided by endobronchial ultrasounds performed during bronchoscopy
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
18 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Diagnostic yield of EBUS-TBNA
Time Frame: 18 months
|
18 months
|
|
Adequacy of EBUS-TBNA samples
Time Frame: 18 months
|
18 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Rocco Trisolini, MD, Maggiore Hospital, Bologna, Italy
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2013
Primary Completion (Actual)
October 1, 2014
Study Completion (Actual)
October 1, 2014
Study Registration Dates
First Submitted
February 23, 2013
First Submitted That Met QC Criteria
February 23, 2013
First Posted (Estimate)
February 26, 2013
Study Record Updates
Last Update Posted (Estimate)
October 7, 2014
Last Update Submitted That Met QC Criteria
October 5, 2014
Last Verified
October 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 13001-Trisolini
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.