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NCT01799382 Clinical Trial

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

Non-small Cell Lung Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01799382
Other study ID # 13001-Trisolini
Secondary ID
Status Completed
Phase N/A
First received February 23, 2013
Last updated October 5, 2014
Start date February 2013
Est. completion date October 2014

Study information
Verified date October 2014
Source Maggiore Bellaria Hospital, Bologna
Contact n/a
Is FDA regulated No
Health authority Italy: Ethics Committee
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 126
Est. completion date October 2014
Est. primary completion date October 2014
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 85 Years
Eligibility 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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
Italy Maggiore Hospital Bologna Emilia Romagna

Sponsors (1)
Lead Sponsor Collaborator
Maggiore Bellaria Hospital, Bologna

Country where clinical trial is conducted

Italy, 

Outcome
Type Measure Description Time frame Safety issue
Primary Mutational analysis of epidermal growth factor receptor (EGFR), K-ras, and ALK (anaplastic lymphoma kinase) genes 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 No
Secondary Diagnostic yield of EBUS-TBNA 18 months No
Secondary Adequacy of EBUS-TBNA samples 18 months No
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