NCT03971175

Influence of Biopsy Technique on Moleculargenetic Tumor Characterisation in NSCLC

A Prospective, Randomized, Single Blinded Multicentre Trial to Evaluate Molecular Genetic Characterisation of Primary Diagnosed or Relapsed Non Small Cell Lung Cancer by Single or Combination of Diagnostic Procedures

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 540 (estimated)
• Sponsor: University Hospital Tuebingen · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Study design Prospective multicentre explorative randomized single blinded study to evaluate accuracy of molecular genetic characterisation of NSCLC. Patients with suspected lung cancer are randomized in a 1:1-setting for bronchoscopic tumor tissue either by forceps or by cryobiopsy. Apart from the bronchoscopic techniques liquid biopsy of peripheral blood and if feasible transbronchial needle aspiration with or without endobronchial ultrasound guidance are performed for in all patients. Objectives Primary Objective: assessment of differences in detection of molecular genetic alterations in NSCLC between bronchoscopic forceps biopsy and bronchoscopic cryobiopsy Secondary Objective: assessment of differences in detection of molecular genetic alterations in NSCLC between * liquid biopsy, solid tumor tissue by bronchoscopic techniques, cytologic material by TBNA * combination of methods (tissue biopsy, TBNA and liquid biopsy) and single techniques * naïve and processed tumor tissue specimen (eg. microdissection) To assess differences in side effects e.g. periinterventional bleeding Explorative Objective: To explore tumor mutational burden with regard to * solid tumor tissue by bronchoscopic forceps biopsy by bronchoscopic cryobiopsy * cytologic material by (EBUS-guided) TBNA * liquid biopsy Target subject population Patients with suspected lung cancer or proven NSCLC and visible tumor suspicious lesion(s) requiring tissue diagnosis form the study population of this trial.

Conditions

• Carcinoma, Non-Small-Cell Lung
• Pathology, Molecular

Interventions

Type	Name	Description
PROCEDURE	Forceps biopsy	Endobronchial biopsy with the forceps
PROCEDURE	Cryobiopsy	Endobronchial biopsy with the cryobiopsy probe

Timeline

• Start date: 2018-12-19
• Primary completion: 2022-09-30
• Completion: 2023-06-30
• First posted: 2019-06-03
• Last updated: 2022-07-26

Locations

1 site across 1 country: Germany