Influence of Biopsy Technique on Molecular Genetic Tumor Characterization in Non-Small Cell Lung Cancer—The Prospective, Randomized, Single-Blinded, Multicenter PROFILER Study Protocol
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 cont...
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| Format: | Article |
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MDPI AG
2020-07-01
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| Series: | Diagnostics |
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| Online Access: | https://www.mdpi.com/2075-4418/10/7/459 |
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| author | 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 |
| author_facet | 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 |
| author_sort | Maik Haentschel |
| collection | DOAJ |
| description | 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. |
| first_indexed | 2024-03-10T18:39:10Z |
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| id | doaj.art-164524e895c94c218129cbf72bb795ed |
| institution | Directory Open Access Journal |
| issn | 2075-4418 |
| language | English |
| last_indexed | 2024-03-10T18:39:10Z |
| publishDate | 2020-07-01 |
| publisher | MDPI AG |
| record_format | Article |
| series | Diagnostics |
| spelling | doaj.art-164524e895c94c218129cbf72bb795ed2023-11-20T05:58:47ZengMDPI AGDiagnostics2075-44182020-07-0110745910.3390/diagnostics10070459Influence of Biopsy Technique on Molecular Genetic Tumor Characterization in Non-Small Cell Lung Cancer—The Prospective, Randomized, Single-Blinded, Multicenter PROFILER Study ProtocolMaik Haentschel0Michael Boeckeler1Irina Bonzheim2Florian Schimmele3Werner Spengler4Franz Stanzel5Christoph Petermann6Kaid Darwiche7Lars Hagmeyer8Reinhard Buettner9Markus Tiemann10Hans-Ulrich Schildhaus11Rainer Muche12Hans Boesmueller13Felix Everinghoff14Robert Mueller15Bijoy Atique16Richard A. Lewis17Lars Zender18Falko Fend19Juergen Hetzel20Department of Medical Oncology and Pneumology, Eberhard Karls University, 72076 Tübingen, GermanyDepartment of Medical Oncology and Pneumology, Eberhard Karls University, 72076 Tübingen, GermanyInstitute of Pathology and Neuropathology, Reference Center for Haematopathology University Hospital, Tuebingen Eberhard-Karls-University, 72076 Tübingen, GermanyDepartment of Internal Medicine, Gastroenterology and Tumor Medicine, Paracelsus Hospital, 73760 Ostfildern-Ruit, GermanyDepartment of Medical Oncology and Pneumology, Eberhard Karls University, 72076 Tübingen, GermanyCenter for Pneumology, 58675 Hemer, GermanyDepartment for Pulmonary Diseases, Asklepios-Klinik Harburg, 21075 Hamburg, GermanyDepartment of Interventional Pneumology, Ruhrlandklinik, University Hospital Essen, University of Duisburg-Essen, 45239 Essen, GermanyClinic for Pneumology and Allergology, Center of Sleep Medicine and Respiratory Care, Hospital Bethanien Solingen, 42699 Solingen, GermanyInstitute of Pathology, University Hospital of Cologne, 50937 Cologne, GermanyInstitute for Hematopathology Hamburg, 22547 Hamburg, GermanyDepartment of Pathology, University Medicine Essen—Ruhrlandklinik, University Duisburg-Essen, 45147 Essen, GermanyInstitute of Epidemiology and Medical Biometry, Ulm University, 89075 Ulm, GermanyInstitute of Pathology and Neuropathology, Reference Center for Haematopathology University Hospital, Tuebingen Eberhard-Karls-University, 72076 Tübingen, GermanyDepartment of Medical Oncology and Pneumology, Eberhard Karls University, 72076 Tübingen, GermanyDepartment of Medical Oncology and Pneumology, Eberhard Karls University, 72076 Tübingen, GermanyDepartment of Medical Oncology and Pneumology, Eberhard Karls University, 72076 Tübingen, GermanyNPARU, University of Worcester, Worcester WR2 6AJ, UKDepartment of Medical Oncology and Pneumology, Eberhard Karls University, 72076 Tübingen, GermanyInstitute of Pathology and Neuropathology, Reference Center for Haematopathology University Hospital, Tuebingen Eberhard-Karls-University, 72076 Tübingen, GermanyDepartment of Medical Oncology and Pneumology, Eberhard Karls University, 72076 Tübingen, GermanyThe 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.https://www.mdpi.com/2075-4418/10/7/459NSCLCmolecular genetic characterizationbronchoscopycryobiopsyforceps biopsynext generation sequencing |
| spellingShingle | 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 Influence of Biopsy Technique on Molecular Genetic Tumor Characterization in Non-Small Cell Lung Cancer—The Prospective, Randomized, Single-Blinded, Multicenter PROFILER Study Protocol Diagnostics NSCLC molecular genetic characterization bronchoscopy cryobiopsy forceps biopsy next generation sequencing |
| title | Influence of Biopsy Technique on Molecular Genetic Tumor Characterization in Non-Small Cell Lung Cancer—The Prospective, Randomized, Single-Blinded, Multicenter PROFILER Study Protocol |
| title_full | Influence of Biopsy Technique on Molecular Genetic Tumor Characterization in Non-Small Cell Lung Cancer—The Prospective, Randomized, Single-Blinded, Multicenter PROFILER Study Protocol |
| title_fullStr | Influence of Biopsy Technique on Molecular Genetic Tumor Characterization in Non-Small Cell Lung Cancer—The Prospective, Randomized, Single-Blinded, Multicenter PROFILER Study Protocol |
| title_full_unstemmed | Influence of Biopsy Technique on Molecular Genetic Tumor Characterization in Non-Small Cell Lung Cancer—The Prospective, Randomized, Single-Blinded, Multicenter PROFILER Study Protocol |
| title_short | Influence of Biopsy Technique on Molecular Genetic Tumor Characterization in Non-Small Cell Lung Cancer—The Prospective, Randomized, Single-Blinded, Multicenter PROFILER Study Protocol |
| title_sort | influence of biopsy technique on molecular genetic tumor characterization in non small cell lung cancer the prospective randomized single blinded multicenter profiler study protocol |
| topic | NSCLC molecular genetic characterization bronchoscopy cryobiopsy forceps biopsy next generation sequencing |
| url | https://www.mdpi.com/2075-4418/10/7/459 |
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