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Influence of Biopsy Technique on Moleculargenetic Tumor Characterisation in NSCLC — PROFILER  

Carcinoma, Non-Small-Cell Lung Clinical Trial

Official title:
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

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03971175
Study type Interventional
Source University Hospital Tuebingen
Contact Maik Haentschel, MD
Phone +49707129
Email maik.haentschel@med.uni-tuebingen.de
Status Recruiting
Phase N/A
Start date December 19, 2018
Completion date June 30, 2023
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