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

Not Applicable
Completed
Conditions
Non-small Cell Lung Cancer
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
Primary Outcome Measures
NameTimeMethod
Mutational analysis of epidermal growth factor receptor (EGFR), K-ras, and ALK (anaplastic lymphoma kinase) genes18 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
NameTimeMethod
Diagnostic yield of EBUS-TBNA18 months
Adequacy of EBUS-TBNA samples18 months

Trial Locations

Locations (1)

Maggiore Hospital

🇮🇹

Bologna, Emilia Romagna, Italy

Maggiore Hospital
🇮🇹Bologna, Emilia Romagna, Italy

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