Influence of Biopsy Technique on Molecular Genetic Tumor Characterization in Non-Small Cell Lung Cancer—The Prospective, Randomized, Single-Blinded, Multicenter PROFILER Study Protocol
Maik Haentschel,
Michael Boeckeler,
Irina Bonzheim,
Florian Schimmele,
Werner Spengler,
Franz Stanzel,
Christoph Petermann,
Kaid Darwiche,
Lars Hagmeyer,
Reinhard Buettner,
Markus Tiemann,
Hans-Ulrich Schildhaus,
Rainer Muche,
Hans Boesmueller,
Felix Everinghoff,
Robert Mueller,
Bijoy Atique,
Richard A. Lewis,
Lars Zender,
Falko Fend,
Juergen Hetzel
Affiliations
Maik Haentschel
Department of Medical Oncology and Pneumology, Eberhard Karls University, 72076 Tübingen, Germany
Michael Boeckeler
Department of Medical Oncology and Pneumology, Eberhard Karls University, 72076 Tübingen, Germany
Irina Bonzheim
Institute of Pathology and Neuropathology, Reference Center for Haematopathology University Hospital, Tuebingen Eberhard-Karls-University, 72076 Tübingen, Germany
Florian Schimmele
Department of Internal Medicine, Gastroenterology and Tumor Medicine, Paracelsus Hospital, 73760 Ostfildern-Ruit, Germany
Werner Spengler
Department of Medical Oncology and Pneumology, Eberhard Karls University, 72076 Tübingen, Germany
Franz Stanzel
Center for Pneumology, 58675 Hemer, Germany
Christoph Petermann
Department for Pulmonary Diseases, Asklepios-Klinik Harburg, 21075 Hamburg, Germany
Kaid Darwiche
Department of Interventional Pneumology, Ruhrlandklinik, University Hospital Essen, University of Duisburg-Essen, 45239 Essen, Germany
Lars Hagmeyer
Clinic for Pneumology and Allergology, Center of Sleep Medicine and Respiratory Care, Hospital Bethanien Solingen, 42699 Solingen, Germany
Reinhard Buettner
Institute of Pathology, University Hospital of Cologne, 50937 Cologne, Germany
Markus Tiemann
Institute for Hematopathology Hamburg, 22547 Hamburg, Germany
Hans-Ulrich Schildhaus
Department of Pathology, University Medicine Essen—Ruhrlandklinik, University Duisburg-Essen, 45147 Essen, Germany
Rainer Muche
Institute of Epidemiology and Medical Biometry, Ulm University, 89075 Ulm, Germany
Hans Boesmueller
Institute of Pathology and Neuropathology, Reference Center for Haematopathology University Hospital, Tuebingen Eberhard-Karls-University, 72076 Tübingen, Germany
Felix Everinghoff
Department of Medical Oncology and Pneumology, Eberhard Karls University, 72076 Tübingen, Germany
Robert Mueller
Department of Medical Oncology and Pneumology, Eberhard Karls University, 72076 Tübingen, Germany
Bijoy Atique
Department of Medical Oncology and Pneumology, Eberhard Karls University, 72076 Tübingen, Germany
Richard A. Lewis
NPARU, University of Worcester, Worcester WR2 6AJ, UK
Lars Zender
Department of Medical Oncology and Pneumology, Eberhard Karls University, 72076 Tübingen, Germany
Falko Fend
Institute of Pathology and Neuropathology, Reference Center for Haematopathology University Hospital, Tuebingen Eberhard-Karls-University, 72076 Tübingen, Germany
Juergen Hetzel
Department of Medical Oncology and Pneumology, Eberhard Karls University, 72076 Tübingen, Germany
The detection of molecular alterations is crucial for the individualized treatment of advanced non-small cell lung cancer (NSCLC). Missing targetable alterations may have a major impact on patient’s progression free and overall survival. Although laboratory testing for molecular alterations has continued to improve; little is known about how biopsy technique affects the detection rate of different mutations. In the retrospective study detection rate of epidermal growth factor (EGFR) mutations in tissue extracted by bronchoscopic cryobiopsy (CB was significantly higher compared to other standard biopsy techniques. This prospective, randomized, multicenter, single blinded study evaluates the accuracy of molecular genetic characterization of NSCLC for different cell sampling techniques. Key inclusion criteria are suspected lung cancer or the suspected relapse of known NSCLC that is bronchoscopically visible. Patients will be randomized, either to have a CB or a bronchoscopic forceps biopsy (FB). If indicated, a transbronchial needle aspiration (TBNA) of suspect lymph nodes will be performed. Blood liquid biopsy will be taken before tissue biopsy. The primary endpoint is the detection rate of molecular genetic alterations in NSCLC, using CB and FB. Secondary endpoints are differences in the combined detection of molecular genetic alterations between FB and CB, TBNA and liquid biopsy. This trial plans to recruit 540 patients, with 178 evaluable patients per study cohort. A histopathological and molecular genetic evaluation will be performed by the affiliated pathology departments of the national network for genomic medicine in lung cancer (nNGM), Germany. We will compare the diagnostic value of solid tumor tissue, lymph node cells and liquid biopsy for the molecular genetic characterization of NSCLC. This reflects a real world clinical setting, with potential direct impact on both treatment and survival.
