Completed

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

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What is being tested

Rapid on-site evaluation

+ EBUS-TBNA

+ EBUS-TBNA

OtherDevice
Who is being recruted

Bronchial Neoplasms+7

+ Carcinoma, Bronchogenic

+ Lung Diseases

From 18 to 85 Years
+5 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Diagnostic Study

Interventional
Study Start: February 2013
See protocol details

Summary

Principal SponsorMaggiore Bellaria Hospital, Bologna
Last updated: October 7, 2014
Sourced from a government-validated database.Claim as a partner

Study start date: February 1, 2013

Actual date on which the first participant was enrolled.

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.

NCT01799382
Principal SponsorMaggiore Bellaria Hospital, Bologna
Last updated: October 7, 2014
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

126 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Diagnostic Study

Diagnostic studies focus on improving how we detect or confirm a disease. They test new tools or techniques that could provide faster or more accurate diagnoses.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 85 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Bronchial NeoplasmsCarcinoma, BronchogenicLung DiseasesLung NeoplasmsNeoplasmsNeoplasms by SiteRespiratory Tract DiseasesRespiratory Tract NeoplasmsThoracic NeoplasmsCarcinoma, Non-Small-Cell Lung

Criteria

2 inclusion criteria required to participate
Age > 18 years
Suspected hilar or mediastinal lymph node metastasis from lung cancer
3 exclusion criteria prevent from participating
Pregnancy
Refusal to sign informed consent
Uncontrolled coagulopathy

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Patients in this arm will undergo rapid-on site evaluation of samples obtained with EBUS-TBNA

Group II

Active Comparator
Patients in this arm will undergo EBUS-TBNA without rapid on-site evaluation

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Maggiore Hospital

Bologna, ItalyOpen Maggiore Hospital in Google Maps
CompletedOne Study Center