The Role of Interventional Pulmonology, Microbiota and Immune Response in the Patient With Lung Cancer

Study Overview
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Brief Summary
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This study is designed to evaluate complications, specificity, diagnostic yield of radial endobronchial ultrasound guided transbronchial cryobiopsy and transbronchial forceps biopsy with fluoroscopy in the diagnosis of peripheral pulmonary lesion; the interplay between non-small-cell lung cancer associated-bacteria along the gut-lung axis and immune response in the cancer microenvironment.

Official Title
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Observational Participants Not Assigned to Intervention(s) Based on a Protocol; Typically in Context of Routine Care

Conditions
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Lung Cancer

Intervention / Treatment
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* Diagnostic Test: Transbronchial forceps biopsy
* Diagnostic Test: Transbronchial forceps biopsy+Transbronchial cryobiopsy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients with peripheral lung lesion suspected of lung cancer detected on the chest computed tomography (CT) and RP-EBUS scans Control group - patients without non-small cell lung cancer Written (signed) Informed Consent to participate in the study Exclusion Criteria: severe hypoxemia (partial pressure of oxygen (pO2)< 60 mmHg) or hypercapnia (carbon dioxide partial pressure (pCO2)> 50 mmHg), bleeding disorders The diffusing capacity for carbon monoxide (DLCOc)< 35 %, forced expiratory volume in one second (FEV1) < 800 ml or FEV 1 < 30 %, peripheral lung tumor was not visualised by RP-EBUS longer than 30 minutes large vessels (more than 3 mm) near the tumor on the CT scan, technically difficult to introduce cryoprobe and/or endobronchial blocker to current bronchi segment or subsegment, excessive bleeding after transbronchial forceps biopsy, which was needed extra intervention to stop bleeding.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Transbronchial forceps biopsy<br>Patients, whose transbronchial forceps biopsy was performed | Diagnostic Test: Transbronchial forceps biopsy<br>* All patients with peripheral lung lesion suspected of lung cancer detected on the chest computed tomography (CT) and mini probe endobronchial ultrasound (RP-EBUS) scans were enrolled. Transbronchial forceps biopsy (TBFB) was performed for all these patients.<br>|
| Active Comparator: Transbronchial forceps biopsy+Transbronchial cryobiopsy<br>Patients, whose transbronchial forceps biopsy and transbronchial cryobiopsy were performed as well | Diagnostic Test: Transbronchial forceps biopsy+Transbronchial cryobiopsy<br>* All patients with peripheral lung lesion suspected of lung cancer detected on the chest computed tomography (CT) and RP-EBUS scans were enrolled. TBFB was performed for all these patients. In addition, all of these patients, with no contraindications, underwent transbronchial cryobiopsy (TBCB)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| progression-free survival |  | one year after enrolment to the study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| overall survival |  | 3 years after enrolment to the study | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cryobiopsy, lung cancer, gut-lung microbiota, immune system