NCT01799382

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
126

participants targeted

Target at P75+ for not_applicable nonsmall-cell-lung-cancer

Timeline
Completed

Started Feb 2013

Shorter than P25 for not_applicable nonsmall-cell-lung-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2013

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

February 23, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 26, 2013

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2014

Completed
Last Updated

October 7, 2014

Status Verified

October 1, 2014

Enrollment Period

1.7 years

First QC Date

February 23, 2013

Last Update Submit

October 5, 2014

Conditions

Non-small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

  • 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

    18 months

Secondary Outcomes (2)

  • Diagnostic yield of EBUS-TBNA

    18 months

  • Adequacy of EBUS-TBNA samples

    18 months

Study Arms (2)

EBUS-TBNA + Rapid on-site evaluation

EXPERIMENTAL

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

Other: Rapid on-site evaluationDevice: EBUS-TBNA

EBUS-TBNA

ACTIVE COMPARATOR

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

Device: EBUS-TBNA

Interventions

Rapid on-site evaluationOTHER

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 + Rapid on-site evaluation
EBUS-TBNADEVICE

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

EBUS-TBNAEBUS-TBNA + Rapid on-site evaluation

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age \> 18 years
  • Suspected hilar or mediastinal lymph node metastasis from lung cancer

You may not qualify if:

  • Pregnancy
  • Uncontrolled coagulopathy
  • Refusal to sign informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Maggiore Hospital

Bologna, Emilia-Romagna, 40133, Italy

Location

Related Publications (1)

  • 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.

    PMID: 26158441DERIVED

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Rapid On-site Evaluation

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Point-of-Care TestingPoint-of-Care SystemsPatient Care ManagementHealth Services Administration

Study Officials

  • Rocco Trisolini, MD

    Maggiore Hospital, Bologna, Italy

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D.

Study Record Dates

First Submitted

February 23, 2013

First Posted

February 26, 2013

Study Start

February 1, 2013

Primary Completion

October 1, 2014

Study Completion

October 1, 2014

Last Updated

October 7, 2014

Record last verified: 2014-10

Locations

IT(1)