Universität zu Köln

Haentschel, Maik, Boeckeler, Michael, Bonzheim, Irina, Schimmele, Florian, Spengler, Werner, Stanzel, Franz, Petermann, Christoph, Darwiche, Kaid, Hagmeyer, Lars, Buettner, Reinhard, Tiemann, Markus, Schildhaus, Hans-Ulrich, Muche, Rainer, Boesmueller, Hans, Everinghoff, Felix, Mueller, Robert, Atique, Bijoy, Lewis, Richard A., Zender, Lars, Fend, Falko and Hetzel, Juergen (2020). 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, 10 (7). BASEL: MDPI. ISSN 2075-4418

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Abstract

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.

Item Type:	Journal Article
Creators:	Creators Email ORCID ORCID Put Code Haentschel, Maik UNSPECIFIED UNSPECIFIED UNSPECIFIED Boeckeler, Michael UNSPECIFIED UNSPECIFIED UNSPECIFIED Bonzheim, Irina UNSPECIFIED UNSPECIFIED UNSPECIFIED Schimmele, Florian UNSPECIFIED UNSPECIFIED UNSPECIFIED Spengler, Werner UNSPECIFIED UNSPECIFIED UNSPECIFIED Stanzel, Franz UNSPECIFIED UNSPECIFIED UNSPECIFIED Petermann, Christoph UNSPECIFIED UNSPECIFIED UNSPECIFIED Darwiche, Kaid UNSPECIFIED UNSPECIFIED UNSPECIFIED Hagmeyer, Lars UNSPECIFIED UNSPECIFIED UNSPECIFIED Buettner, Reinhard UNSPECIFIED UNSPECIFIED UNSPECIFIED Tiemann, Markus UNSPECIFIED UNSPECIFIED UNSPECIFIED Schildhaus, Hans-Ulrich UNSPECIFIED UNSPECIFIED UNSPECIFIED Muche, Rainer UNSPECIFIED UNSPECIFIED UNSPECIFIED Boesmueller, Hans UNSPECIFIED UNSPECIFIED UNSPECIFIED Everinghoff, Felix UNSPECIFIED UNSPECIFIED UNSPECIFIED Mueller, Robert UNSPECIFIED UNSPECIFIED UNSPECIFIED Atique, Bijoy UNSPECIFIED UNSPECIFIED UNSPECIFIED Lewis, Richard A. UNSPECIFIED UNSPECIFIED UNSPECIFIED Zender, Lars UNSPECIFIED UNSPECIFIED UNSPECIFIED Fend, Falko UNSPECIFIED UNSPECIFIED UNSPECIFIED Hetzel, Juergen UNSPECIFIED UNSPECIFIED UNSPECIFIED
URN:	urn:nbn:de:hbz:38-327633
DOI:	10.3390/diagnostics10070459
Journal or Publication Title:	Diagnostics
Volume:	10
Number:	7
Date:	2020
Publisher:	MDPI
Place of Publication:	BASEL
ISSN:	2075-4418
Language:	English
Faculty:	Unspecified
Divisions:	Unspecified
Subjects:	no entry
Uncontrolled Keywords:	Keywords Language TRANSBRONCHIAL NEEDLE ASPIRATION; TYROSINE KINASE INHIBITORS; GROWTH-FACTOR RECEPTOR; AMERICAN PATHOLOGISTS/INTERNATIONAL ASSOCIATION; CLINICAL ONCOLOGY ENDORSEMENT; EGFR MUTATION HETEROGENEITY; OPEN-LABEL; PHASE-III; 1ST-LINE TREATMENT; TESTING GUIDELINE Multiple languages Medicine, General & Internal Multiple languages
URI:	http://kups.ub.uni-koeln.de/id/eprint/32763