An observational study in Lung Cancer, sponsored by University of Milan. Completed at 4 sites in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-10-01.
Sponsored by University of Milan · Observational
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)
Lung cancer is by far the leading cause of cancer death among both men and women worldwide. Non-Small Cell Lung Cancer (NSCLC) represents about 80-90% of all lung cancers. Endoscopic ultrasound with bronchoscope fine needle aspiration (EUS-B-FNA) is a safe and accurate technique that has been mostly described for the diagnosis and the mediastinal nodal staging of NSCLC, as a complementary technique to endobronchial ultrasound trans-bronchial needle aspiration (EBUS-TBNA) or when EBUS-TBNA may be difficult and/or contraindicated for clinical reasons (e.g. excessive cough, respiratory failure etc).
Few retrospective studies evaluated the sensitivity and the safety of this technique in the diagnosis of parenchymal pulmonary lesions suspected for lung cancer, in contact or adjacent to the esophagus. Few data are available on the adequacy of the samples obtained by EUS-B-FNA for molecular analysis in NSCLC. The main predictors of success are still unclear.
The primary aim of this prospective study is to evaluate the diagnostic accuracy of EUS-B-FNA in the diagnosis of malignant parenchymal lung lesions. The Investigators will also evaluate the safety and tolerability of the technique, the main predictors of success and the adequacy of samples obtained for molecular analysis in patients with NSCLC
7,243 studies on the registry are indexed under Lung Neoplasms; 1,557 are open to participants now.
This study's enrollment of 107 is below the median of 189 across 1,514 observational studies indexed under Lung Neoplasms.
Browse Lung Neoplasms studies →University of Milan is the lead sponsor of 177 studies on the registry; 27 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
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:
Exclusion Criteria:
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
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
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.
Time frame: At study completion (expected February 2021)
Absolute and relative frequency of adequate samples for molecular analysis in NSCLC following assessment by pathologist/molecular biologist
Proportional number (percentage) of samples obtained with EUS-B-FNA containing sufficient material (i.e. malignant cells) for molecular analysis in NSCLC following assessment by a pathologist/molecular biologist. A specific unit of measure is not included, being the computation of the present outcome based on the absolute number of malignant cells in the single sample.
Time frame: At study completion (expected February 2021)
Detection of predictors of successful aspirate based on the implementation of regression models
Implementation of regression models (logistic regression analysis) to detect variables related to a successful aspirate: anatomical (i.e. lung, lobe of the lesion), endoscopic (type of endoscope, type of needle, number of needle passes, needle aspiration technique), pathological (presence/absence of rapid on-site evaluation (ROSE), health personnel performing ROSE (i.e pathologist, respiratory physician, cytotechnician), pathological technique used for diagnosis and molecular analysis (smear, cell-block, liquid based cytology). A specific unit of measure is not included, being the computation of the present variables based on the measurement of absolute numbers not recorded with a specific unit of measure. The unit of measure is basically identified by the single element of the variable.
Time frame: At study completion (expected February 2021)
Safety (number of adverse events) of EUS-B-FNA through CTCAE v4.0
Incidence rate and qualitative and quantitative description of adverse events in patients undergoing EUS-B-FNA. A specific unit of measure is not included, being the computation of the present outcome based on the absolute number of the adverse events detected by the attending physician.
Time frame: Until 24 hours after the procedure
This study is completed, as verified in Sep 2021. You cannot join it, but the record below documents what was studied.
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University of Milan