Role of Rapid On-site Evaluation for Mutational Analysis of EBUS-TBNA Specimens
Not Applicable
Completed
- Conditions
- Non-small Cell Lung Cancer
- Interventions
- Other: Rapid on-site evaluationDevice: EBUS-TBNA
- Registration Number
- NCT01799382
- Lead Sponsor
- Maggiore Bellaria Hospital, Bologna
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 126
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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description EBUS-TBNA + Rapid on-site evaluation EBUS-TBNA Patients in this arm will undergo rapid-on site evaluation of samples obtained with EBUS-TBNA EBUS-TBNA + Rapid on-site evaluation Rapid on-site evaluation Patients in this arm will undergo rapid-on site evaluation of samples obtained with EBUS-TBNA EBUS-TBNA EBUS-TBNA Patients in this arm will undergo EBUS-TBNA without rapid on-site evaluation
- Primary Outcome Measures
Name Time Method Mutational analysis of epidermal growth factor receptor (EGFR), K-ras, and ALK (anaplastic lymphoma kinase) genes 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
Name Time Method Diagnostic yield of EBUS-TBNA 18 months Adequacy of EBUS-TBNA samples 18 months
Trial Locations
- Locations (1)
Maggiore Hospital
🇮🇹Bologna, Emilia Romagna, Italy