A Study on the Epidemiology and Testing of Human Epidermal Growth Factor-Receptor 2 (HER2) in Breast Cancer in Germany
- Conditions
- Breast Cancer
- Registration Number
- NCT02666261
- Lead Sponsor
- Hoffmann-La Roche
- Brief Summary
This non-interventional study will collect data from routine diagnostics on HER2 testing of breast cancer in Germany.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 15000
- Samples derived from men and women of age greater than or equal to (>/=) 18 years
- Samples derived from participants with any stage of histologically confirmed invasive breast cancer with HER2 diagnostics performed within routine (histo-)pathological workup or
- (Histo-)Pathological work-up of the tumor sample as at or after start of this study
- Available information on the year of birth of the participant
- No pre-selection of tumor samples is allowed. Tumor samples have to be documented consecutively in the order of their (histo-)pathological work-up.
- Sample derived from participants with any stage of breast cancer with no HER2 diagnostics performed at the time of routine (histo-)pathological work-up.
- Samples derived prior to the start of this study.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Number of HER2 Positive Samples 1 day (this is a single time point study)
- Secondary Outcome Measures
Name Time Method Number of HER2 Positive Samples by Applied Method of Tissue Fixation 1 day (this is a single time point study) Number of HER2 Positive Samples by Round Robin Tests 1 day (this is a single time point study) Number of HER2 Positive Samples by Carcinoma Subtype (No Special Type\Ductal, Lobular, Other Special Type) 1 day (this is a single time point study) Number of HER2 Positive Samples by Sample Extraction (Biopsy versus Resectate) 1 day (this is a single time point study) Number of HER2 Positive Samples by Sample Source (Primary Tumor, Local Lymph Nodes, Metastasis) 1 day (this is a single time point study) Number of HER2 Positive Samples by Testing Platform 1 day (this is a single time point study) Number of HER2 Positive Samples by Automation of Testing 1 day (this is a single time point study) Number of HER2 Positive Samples by Tumor Grading 1 day (this is a single time point study) Number of HER2 Positive Samples by Participant Age 1 day (this is a single time point study) Number of HER2 Positive Samples by Tumor-Node-Metastasis (TNM) Classification 1 day (this is a single time point study) Number of HER2 Positive Samples by Scoring Algorithm 1 day (this is a single time point study) Number of HER2 Positive Samples by Antibody Clone Antibody or Test Certification 1 day (this is a single time point study) Number of HER2 Positive Samples by Institute's Certification 1 day (this is a single time point study) Number of HER2 Positive Samples by Institute's Accreditation 1 day (this is a single time point study) Number of HER2 Positive Samples by Hormone Receptor Status 1 day (this is a single time point study)
Trial Locations
- Locations (64)
OptiPath Gemeinschaftspraxis für Pathologie
🇩🇪Frankfurt, Germany
Gemeinschaftspraxis für Pathologie Dr. Dykgers, Dr. Langwieder, Dr. Rees
🇩🇪Dortmund, Germany
Universitätsklinikum Erlangen; Pathologisches Institut
🇩🇪Erlangen, Germany
Gemeinschaftspraxis; Institut für Pathologie am Evangelischen Waldkrankenhaus
🇩🇪Berlin - Spandau, Germany
Klinikum Augsburg; Institut für Pathologie
🇩🇪Augsburg, Germany
Praxis am St. Agnes-Hospital Bocholt
🇩🇪Bocholt, Germany
Institut für Pathologie, MVZ am Lukaskrankenhaus
🇩🇪Grevenbroich, Germany
Gemeinschaftspraxis für Pathologie Ingolstadt Dr. König, Dr. Popp, Prof. Dr. Adam
🇩🇪Ingolstadt, Germany
Vivantes Klinikum Neukölln; Fachbereich Pathologie
🇩🇪Berlin, Germany
Sozialstiftung Bamberg; Institut für Pathologie
🇩🇪Bamberg, Germany
Klinikum Konstanz gGmbH, Institut und Praxis für Pathologie
🇩🇪Konstanz, Germany
Universitätsklinikum Magdeburg; Institut für Pathologie und Neuropathologie
🇩🇪Magdeburg, Germany
Institut für Pathologie der Universität Münster, Albert Schweitzer Campus, Gebäude D17
🇩🇪Münster, Germany
Pathologisches Institut Recklinghausen
🇩🇪Recklinghausen, Germany
Diakoniekrankenhaus Institut f.Pathologie
🇩🇪Rotenburg, Germany
Institut für Pathologie am Clemenshospital Münster
🇩🇪Münster, Germany
Kliniken der Stadt Köln gGmbH Krankenhaus Merheim
🇩🇪Köln, Germany
Institut für Pathologie, Universitäsklinikum Schleswig-Holstein
🇩🇪Kiel, Germany
Evangelisches Krankenhaus Oberhausen GmbH, Institut f.Pathologie
🇩🇪Oberhausen, Germany
Klinikum Magdeburg GmbH
🇩🇪Magdeburg, Germany
Zentrum für Pathologie, Zytologie und Molekularpathologie Neuss
🇩🇪Neuss, Germany
Gemeinschaftspraxis für Pathologie Stefan Berger, Jörg Linke und Ellen Fietze
🇩🇪Berlin, Germany
Universitätsklinikum Göttingen, Institut für Pathologie
🇩🇪Göttingen, Germany
Universitätsklinikum Halle (Saale), Institut für Pathologie
🇩🇪Halle/Saale, Germany
Pathocom - Gemeinschaftspraxis Bischofsstraße Osnabrück
🇩🇪Osnabrück, Germany
Gemeinschaftspraxis PD Dr.med. Meinald Schultz und Dr.med. Petra Lüders
🇩🇪Stendal, Germany
Klinikum Bayreuth
🇩🇪Bayreuth, Germany
HELIOS Klinikum Emil von Behring Klinik f.Pneumologie Onkologie u.Infektiologie
🇩🇪Berlin, Germany
Institut für Pathologie, Zytologie & Molekularpathologie in Bergisch Gladbach
🇩🇪Bergisch Gladbach, Germany
Institut für Pathologie und Zytologie an der Augusta-Kranken-Anstalt
🇩🇪Bochum, Germany
Evangelisches Krankenhaus BETHESDA zu Duisburg GmbH; Institut für Pathologie
🇩🇪Duisburg, Germany
Krankenhaus Düren gem. GmbH; Institut und Praxisgemeinschaft für Pathologie
🇩🇪Düren, Germany
Universitätsklinikum Freiburg Institut f.Pathologie
🇩🇪Freiburg, Germany
Klinikum Oberberg; Pathologisches Institut Kreiskrankenhaus Gummersbach
🇩🇪Gummersbach, Germany
Klinik am Eichert; Institut für Pathologie
🇩🇪Göppingen, Germany
Gemeinschaftspraxis Dr. Hartmut Fitz, Dr. Sebastian Blasius und PD Dr. Christian August
🇩🇪Hanau, Germany
Fachärzte Dres Tiemann & Schulte Partnerschaft; Institut für Hämatopathologie Hamburg
🇩🇪Hamburg, Germany
Pathologisches Institut
🇩🇪Heidelberg, Germany
Universitätsklinikum Jena; Institut für Pathologie
🇩🇪Jena, Germany
Institut für Pathologie Hildesheim
🇩🇪Hildesheim, Germany
Städtisches Klinikum Karlsruhe gGmbH; Pathologisches Institut
🇩🇪Karlsruhe, Germany
Institut Für Pathologie Nordhessen
🇩🇪Kassel, Germany
Institut für Pathologie Kassel
🇩🇪Kassel, Germany
Gemeinschaftspraxis für Pathologie Lübeck; Turzynski, Lebeau, Gocht, Leuenroth
🇩🇪Lübeck, Germany
Institut f. Pathologie, der Univers. Köln
🇩🇪Köln, Germany
Klinikum Mannheim; Pathologisches Institut
🇩🇪Mannheim, Germany
Klinikum am Steinenberg / Ermstalklinik
🇩🇪Reutlingen, Germany
Robert-Bosch-Krankenhaus; Pathologisches Institut
🇩🇪Stuttgart, Germany
Gemeinschaftspraxis für Pathologie Weiden; am Klinikum Weiden; Giedl, Stelter und Meier
🇩🇪Weiden, Germany
Pathologisches Institut am Allg. KH Stadt Hagen; Stambolis, Wolf von Rhüden, Ruwe
🇩🇪Hagen, Germany
Universitätsklinikum Bonn; Zentrum für Pathologie Pathologisches Institut
🇩🇪Bonn, Germany
Klinikum Coburg GmbH - Institut für Pathologie
🇩🇪Coburg, Germany
Gemeinschaftspraxis für Pathologie Hamm, Dres. Diebold/Niemann
🇩🇪Hamm, Germany
Städtisches Klinikum Dresden; Institut für Pathologie "Georg Schmorl" (Friedrichstadt)
🇩🇪Dresden, Germany
Pathologische Institut Friedrichshafen/Bodensee (Gemeinschaftspraxis für Pathologie und Zytologie)
🇩🇪Friedrichshafen, Germany
Städtisches Klinikum Dessau; Institut für Pathologie
🇩🇪Dessau-Roßlau, Germany
HELIOS Klinikum Schwerin; Frauenklinik
🇩🇪Schwerin, Germany
Kath. Marienkrankenhaus gGmbH
🇩🇪Hamburg, Germany
Dres. Wolfgang Beschow Eckehardt Kupsch Herbert Radner u.w.
🇩🇪Hannover, Germany
Medizinische Hochschule Hannover, Klinik für Frauenheilkunde und Geburtshilfe
🇩🇪Hannover, Germany
Institut für Pathologie
🇩🇪Mühlhausen, Germany
Leopoldina Krankenhaus der Stadt Schweinfurt GmbH; Pathologie
🇩🇪Schweinfurt, Germany
Pathologie München-Nord
🇩🇪München, Germany
Dietrich Bonhoeffer Kliniken Neubrandenburg, Institut für Pathologie
🇩🇪Neubrandenburg, Germany