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

NCT ID: NCT01799382

Last Updated: 2014-10-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

126 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-02-28

Study Completion Date

2014-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Non-small Cell Lung Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Participants

Study Groups

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EBUS-TBNA + Rapid on-site evaluation

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

Group Type EXPERIMENTAL

Rapid on-site evaluation

Intervention Type 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

Intervention Type DEVICE

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

EBUS-TBNA

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

Group Type ACTIVE_COMPARATOR

EBUS-TBNA

Intervention Type DEVICE

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

Interventions

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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.

Intervention Type OTHER

EBUS-TBNA

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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Maggiore Bellaria Hospital, Bologna

OTHER

Sponsor Role lead

Responsible Party

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Rocco Trisolini

M.D.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Rocco Trisolini, MD

Role: PRINCIPAL_INVESTIGATOR

Maggiore Hospital, Bologna, Italy

Locations

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Maggiore Hospital

Bologna, Emilia-Romagna, Italy

Site Status

Countries

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Italy

References

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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.

Reference Type DERIVED
PMID: 26158441 (View on PubMed)

Other Identifiers

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13001-Trisolini

Identifier Type: -

Identifier Source: org_study_id

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