Influence of Biopsy Technique on Molecular Genetic Tumor Characterization in Non-Small Cell Lung Cancer—The Prospective, Randomized, Single-Blinded, Multicenter PROFILER Study Protocol

• DOI: 10.3390/diagnostics10070459
• Publication Date: 2020-07-06T15:07:42Z
• Authors: Maik Haentschel; Michael Boeckeler; Irina Bonzheim; Florian Schimmele; Werner Spengler; Franz Stanzel; Christoph Petermann; Kaid Darwiche; Lars Hagmeyer; Reinhard Buettner; Markus Tiemann; Hans-Ulrich Schil...; Rainer Muche; Hans Boesmueller; Felix Everinghoff; Robert Mueller; Bijoy Atique; Richard A. Lewis; Lars Zender; Falko Fend; Juergen Hetzel
• Keywords: Clinical endpoint

The detection of molecular alterations is crucial for the individualized treatment advanced non-small cell lung cancer (NSCLC). Missing targetable may have a major impact on patient’s progression free and overall survival. Although laboratory testing has continued to improve; little known about how biopsy technique affects rate different mutations. In retrospective study epidermal growth factor (EGFR) mutations in tissue extracted by bronchoscopic cryobiopsy (CB was significantly higher compared other standard techniques. This prospective, randomized, multicenter, single blinded evaluates accuracy genetic characterization NSCLC sampling Key inclusion criteria are suspected or relapse that bronchoscopically visible. Patients will be either CB forceps (FB). If indicated, transbronchial needle aspiration (TBNA) suspect lymph nodes performed. Blood liquid taken before biopsy. primary endpoint NSCLC, using FB. Secondary endpoints differences combined between FB CB, TBNA trial plans recruit 540 patients, with 178 evaluable patients per cohort. A histopathological evaluation performed affiliated pathology departments national network genomic medicine (nNGM), Germany. We compare diagnostic value solid tumor tissue, node cells NSCLC. reflects real world clinical setting, potential direct both