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

  • Italy
    • Emilia Romagna
      • 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
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
Active Comparator: EBUS-TBNA
Patients in this arm will undergo EBUS-TBNA without rapid on-site evaluation
Device: EBUS-TBNA
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.

Sponsor

Maggiore Bellaria Hospital, Bologna

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.

General Publications

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.

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