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Completed

NCT Number: NCT01799382

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

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.

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Key information

Conditions

Non-small Cell Lung Cancer Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Maggiore Hospital

Bologna, Emilia-Romagna, 40133, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Rapid on-site evaluation

Other

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

Device

EBUS-TBNA is a needle aspiration procedure guided by endobronchial ultrasounds performed during bronchoscopy

Primary outcomes

  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 outcomes

  1. Diagnostic yield of EBUS-TBNA

    Time frame: 18 months

  2. Adequacy of EBUS-TBNA samples

    Time frame: 18 months

Sponsors and collaborators

Lead sponsor

Maggiore Bellaria Hospital, Bologna

Other

Registry information

Official study 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

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Feb 26, 2013
Registry last updated
Oct 7, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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