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

Primary Purpose

Non-small Cell Lung Cancer

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Rapid on-site evaluation
EBUS-TBNA
Sponsored by
Maggiore Bellaria Hospital, Bologna
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Non-small Cell Lung Cancer

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Maggiore Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

EBUS-TBNA + Rapid on-site evaluation

EBUS-TBNA

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Diagnostic yield of EBUS-TBNA
Adequacy of EBUS-TBNA samples

Full Information

First Posted
February 23, 2013
Last Updated
October 5, 2014
Sponsor
Maggiore Bellaria Hospital, Bologna
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1. Study Identification

Unique Protocol Identification Number
NCT01799382
Brief Title
Role of Rapid On-site Evaluation for Mutational Analysis of EBUS-TBNA Specimens
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2014
Overall Recruitment Status
Completed
Study Start Date
February 2013 (undefined)
Primary Completion Date
October 2014 (Actual)
Study Completion Date
October 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Maggiore Bellaria Hospital, Bologna

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-small Cell Lung Cancer

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
126 (Actual)

8. Arms, Groups, and Interventions

Arm Title
EBUS-TBNA + Rapid on-site evaluation
Arm Type
Experimental
Arm Description
Patients in this arm will undergo rapid-on site evaluation of samples obtained with EBUS-TBNA
Arm Title
EBUS-TBNA
Arm Type
Active Comparator
Arm Description
Patients in this arm will undergo EBUS-TBNA without rapid on-site evaluation
Intervention Type
Other
Intervention Name(s)
Rapid on-site evaluation
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
EBUS-TBNA
Intervention Description
EBUS-TBNA is a needle aspiration procedure guided by endobronchial ultrasounds performed during bronchoscopy
Primary Outcome Measure Information:
Title
Mutational analysis of epidermal growth factor receptor (EGFR), K-ras, and ALK (anaplastic lymphoma kinase) genes
Description
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
Time Frame
18 months
Secondary Outcome Measure Information:
Title
Diagnostic yield of EBUS-TBNA
Time Frame
18 months
Title
Adequacy of EBUS-TBNA samples
Time Frame
18 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rocco Trisolini, MD
Organizational Affiliation
Maggiore Hospital, Bologna, Italy
Official's Role
Principal Investigator
Facility Information:
Facility Name
Maggiore Hospital
City
Bologna
State/Province
Emilia Romagna
ZIP/Postal Code
40133
Country
Italy

12. IPD Sharing Statement

Citations:
PubMed Identifier
26158441
Citation
Trisolini R, Cancellieri A, Tinelli C, de Biase D, Valentini I, Casadei G, Paioli D, Ferrari F, Gordini G, Patelli M, Tallini G. Randomized Trial of Endobronchial Ultrasound-Guided Transbronchial Needle Aspiration With and Without Rapid On-site Evaluation for Lung Cancer Genotyping. Chest. 2015 Dec;148(6):1430-1437. doi: 10.1378/chest.15-0583.
Results Reference
derived

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

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