NCT03983005

Brief Summary

The aim of this study is to evaluate the diagnostic accuracy, safety and tolerability, predictors of success of EUS-B-FNA in the diagnosis of malignant parenchymal lung lesions. The Investigators will also evaluated the adequacy of samples obtained for molecular analysis in patients with Non-Small Cell Lung Cancer (NSCLC)

Trial Health

87
On Track

Trial Health Score

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

Enrollment
107

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2019

Geographic Reach
1 country

4 active sites

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

May 31, 2019

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

June 1, 2019

Completed
11 days until next milestone

First Posted

Study publicly available on registry

June 12, 2019

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2021

Completed
Last Updated

October 1, 2021

Status Verified

September 1, 2021

Enrollment Period

2 years

First QC Date

June 1, 2019

Last Update Submit

September 30, 2021

Conditions

Lung Cancer

Keywords

Lung cancerEndoscopic ultrasoundEUS-B-FNAMolecular analysisRapid on-site evaluation

Outcome Measures

Primary Outcomes (1)

  • Sensitivity and specificity of EUS-B-FNA in the detection of malignant pulmonary lesions

    Diagnostic accuracy (i.e., sensitivity and specificity) of EUS-B-FNA in the diagnosis of malignant pulmonary parenchymal lesions, discriminating those with a malignant disease in comparison with those without the malignant disease. A specific unit of measure is not included, being the computation of the present outcome based on the absolute number of malignant/non malignant cases to the total number of diagnosed individuals.

    At study completion (expected February 2021)

Secondary Outcomes (3)

  • Absolute and relative frequency of adequate samples for molecular analysis in NSCLC following assessment by pathologist/molecular biologist

    At study completion (expected February 2021)

  • Detection of predictors of successful aspirate based on the implementation of regression models

    At study completion (expected February 2021)

  • Safety (number of adverse events) of EUS-B-FNA through CTCAE v4.0

    Until 24 hours after the procedure

Study Arms (1)

Patients with suspected lung cancer

Patients with pulmonary parenchymal lesions suspected for malignancy in contact or adjacent to the esophagus which can be sampled by EUS-B-FNA

Procedure: EUS-B-FNA

Interventions

EUS-B-FNAPROCEDURE

Endoscopic ultrasound with bronchoscope fine needle aspiration (EUS-B-FNA) is an endoscopic technique based on a trans-esophageal needle aspiration performed by an interventional pulmonologist with the echo-bronchoscope

Also known as: Endoscopic ultrasound with bronchoscope fine needle aspiration
Patients with suspected lung cancer

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with a parenchymal lung lesion suspected for malignancy in contact or adjacent to the esophagus at the CT scan, who need a pathological diagnosis.

You may qualify if:

  • Adult patients with a lung parenchymal lesion suspected for malignancy, in contact or adjacent to the esophagus at the CT scan (with or without mediastinal lymph adenopathies), requiring a pathological diagnosis:
  • which can not be sample by bronchoscopy/EBUS-TBNA or
  • with a previous not diagnostic bronchoscopy/EBUS-TBNA or
  • with clinical/anesthesiological contraindications to bronchoscopy/EBUS-TBNA or
  • with a previous nodal EUS-B-FNA not diagnostic/not adequate at the ROSE
  • Patients with lung parenchymal lesions who are able to sign the informed consent for the study participation

You may not qualify if:

  • Patients with lung parenchymal lesions of known etiology;
  • Patients with lung parenchymal lesions in whom bronchoscopic ultrasound-guided trans- esophageal needle aspiration is contraindicated;
  • Patients with lung parenchymal lesions who refuse/are not able to sign the informed consent for the study participation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

UO Pneumologia dell'Ospedale dell'Angelo

Mestre, Venice, Italy

Location

Pulmonology Unit, AOU "Ospedali Riuniti"; Department of Biomedical Sciences and Public Health, Università Politecnica delle Marche

Ancona, Italy

Location

Respiratory Unit, ASST Santi Paolo e Carlo, San Paolo Hospital, Department of Health Sciences, Università degli Studi di Milano

Milan, 20142, Italy

Location

Unità Operativa Complessa di Pneumologia, Fondazione Policlinico Universitario A. Gemelli IRCCS, Università Cattolica del Sacro Cuore

Rome, Italy

Location

Biospecimen

Retention: SAMPLES WITH DNA

Needle aspirations

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Michele Mondoni, MD

    Respiratory Unit, ASST Santi Paolo e Carlo, San Paolo Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, Principal Investigator

Study Record Dates

First Submitted

June 1, 2019

First Posted

June 12, 2019

Study Start

May 31, 2019

Primary Completion

May 31, 2021

Study Completion

May 31, 2021

Last Updated

October 1, 2021

Record last verified: 2021-09

Locations

IT(4)