Clinical trial · Observational
EUS-B-FNA in the Diagnosis of Malignant Parenchymal Lung Lesions
Observational, Prospective, Multicenter Study on the Diagnostic Accuracy, Safety and Tolerability, Predictors of Success of EUS-B-FNA in the Diagnosis of Malignant Parenchymal Lung Lesions
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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)
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| EUS-B-FNA | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Patients with suspected lung cancer
- description
- Patients with pulmonary parenchymal lesions suspected for malignancy in contact or adjacent to the esophagus which can be sampled by EUS-B-FNA
- interventionNames
- Procedure: EUS-B-FNA
Primary outcomes (1)
- measure
- Sensitivity and specificity of EUS-B-FNA in the detection of malignant pulmonary lesions
- timeFrame
- At study completion (expected February 2021)
- description
- 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.
Secondary outcomes (3)
- measure
- Absolute and relative frequency of adequate samples for molecular analysis in NSCLC following assessment by pathologist/molecular biologist
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Exclusion Criteria: * 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
References
Publications (0)
Data not yet available