Breast Cancer Clinical Trial
Official title:
A Non-interventional Study on the Epidemiology and Testing of HER2 in Breast Cancer in Germany
| NCT number | NCT02666261 |
| Other study ID # | ML29763 |
| Secondary ID | |
| Status | Completed |
| Phase | |
| First received | |
| Last updated | |
| Start date | March 4, 2016 |
| Est. completion date | February 28, 2018 |
| Verified date | March 2019 |
| Source | Hoffmann-La Roche |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
This non-interventional study will collect data from routine diagnostics on HER2 testing of breast cancer in Germany.
| Status | Completed |
| Enrollment | 15000 |
| Est. completion date | February 28, 2018 |
| Est. primary completion date | February 28, 2018 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - 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. Exclusion Criteria: - 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. |
| Country | Name | City | State |
|---|---|---|---|
| Germany | Klinikum Augsburg; Institut für Pathologie | Augsburg | |
| Germany | Sozialstiftung Bamberg; Institut für Pathologie | Bamberg | |
| Germany | Klinikum Bayreuth | Bayreuth | |
| Germany | Institut für Pathologie, Zytologie & Molekularpathologie in Bergisch Gladbach | Bergisch Gladbach | |
| Germany | Gemeinschaftspraxis für Pathologie Stefan Berger, Jörg Linke und Ellen Fietze | Berlin | |
| Germany | HELIOS Klinikum Emil von Behring Klinik f.Pneumologie Onkologie u.Infektiologie | Berlin | |
| Germany | Vivantes Klinikum Neukölln; Fachbereich Pathologie | Berlin | |
| Germany | Gemeinschaftspraxis; Institut für Pathologie am Evangelischen Waldkrankenhaus | Berlin - Spandau | |
| Germany | Praxis am St. Agnes-Hospital Bocholt | Bocholt | |
| Germany | Institut für Pathologie und Zytologie an der Augusta-Kranken-Anstalt | Bochum | |
| Germany | Universitätsklinikum Bonn; Zentrum für Pathologie Pathologisches Institut | Bonn | |
| Germany | Klinikum Coburg GmbH - Institut für Pathologie | Coburg | |
| Germany | Städtisches Klinikum Dessau; Institut für Pathologie | Dessau-Roßlau | |
| Germany | Gemeinschaftspraxis für Pathologie Dr. Dykgers, Dr. Langwieder, Dr. Rees | Dortmund | |
| Germany | Städtisches Klinikum Dresden; Institut für Pathologie "Georg Schmorl" (Friedrichstadt) | Dresden | |
| Germany | Evangelisches Krankenhaus BETHESDA zu Duisburg GmbH; Institut für Pathologie | Duisburg | |
| Germany | Krankenhaus Düren gem. GmbH; Institut und Praxisgemeinschaft für Pathologie | Düren | |
| Germany | Universitätsklinikum Erlangen; Pathologisches Institut | Erlangen | |
| Germany | OptiPath Gemeinschaftspraxis für Pathologie | Frankfurt | |
| Germany | Universitätsklinikum Freiburg Institut f.Pathologie | Freiburg | |
| Germany | Pathologische Institut Friedrichshafen/Bodensee (Gemeinschaftspraxis für Pathologie und Zytologie) | Friedrichshafen | |
| Germany | Klinik am Eichert; Institut für Pathologie | Göppingen | |
| Germany | Universitätsklinikum Göttingen, Institut für Pathologie | Göttingen | |
| Germany | Institut für Pathologie, MVZ am Lukaskrankenhaus | Grevenbroich | |
| Germany | Klinikum Oberberg; Pathologisches Institut Kreiskrankenhaus Gummersbach | Gummersbach | |
| Germany | Pathologisches Institut am Allg. KH Stadt Hagen; Stambolis, Wolf von Rhüden, Ruwe | Hagen | |
| Germany | Universitätsklinikum Halle (Saale), Institut für Pathologie | Halle/Saale | |
| Germany | Fachärzte Dres Tiemann & Schulte Partnerschaft; Institut für Hämatopathologie Hamburg | Hamburg | |
| Germany | Kath. Marienkrankenhaus gGmbH | Hamburg | |
| Germany | Gemeinschaftspraxis für Pathologie Hamm, Dres. Diebold/Niemann | Hamm | |
| Germany | Gemeinschaftspraxis Dr. Hartmut Fitz, Dr. Sebastian Blasius und PD Dr. Christian August | Hanau | |
| Germany | Dres. Wolfgang Beschow Eckehardt Kupsch Herbert Radner u.w. | Hannover | |
| Germany | Medizinische Hochschule Hannover, Klinik für Frauenheilkunde und Geburtshilfe | Hannover | |
| Germany | Pathologisches Institut | Heidelberg | |
| Germany | Institut für Pathologie Hildesheim | Hildesheim | |
| Germany | Gemeinschaftspraxis für Pathologie Ingolstadt Dr. König, Dr. Popp, Prof. Dr. Adam | Ingolstadt | |
| Germany | Universitätsklinikum Jena; Institut für Pathologie | Jena | |
| Germany | Städtisches Klinikum Karlsruhe gGmbH; Pathologisches Institut | Karlsruhe | |
| Germany | Institut für Pathologie Kassel | Kassel | |
| Germany | Institut Für Pathologie Nordhessen | Kassel | |
| Germany | Institut für Pathologie, Universitäsklinikum Schleswig-Holstein | Kiel | |
| Germany | Institut f. Pathologie, der Univers. Köln | Köln | |
| Germany | Kliniken der Stadt Köln gGmbH Krankenhaus Merheim | Köln | |
| Germany | Klinikum Konstanz gGmbH, Institut und Praxis für Pathologie | Konstanz | |
| Germany | Gemeinschaftspraxis für Pathologie Lübeck; Turzynski, Lebeau, Gocht, Leuenroth | Lübeck | |
| Germany | Klinikum Magdeburg GmbH | Magdeburg | |
| Germany | Universitätsklinikum Magdeburg; Institut für Pathologie und Neuropathologie | Magdeburg | |
| Germany | Klinikum Mannheim; Pathologisches Institut | Mannheim | |
| Germany | Institut für Pathologie | Mühlhausen | |
| Germany | Pathologie München-Nord | München | |
| Germany | Institut für Pathologie am Clemenshospital Münster | Münster | |
| Germany | Institut für Pathologie der Universität Münster, Albert Schweitzer Campus, Gebäude D17 | Münster | |
| Germany | Dietrich Bonhoeffer Kliniken Neubrandenburg, Institut für Pathologie | Neubrandenburg | |
| Germany | Zentrum für Pathologie, Zytologie und Molekularpathologie Neuss | Neuss | |
| Germany | Evangelisches Krankenhaus Oberhausen GmbH, Institut f.Pathologie | Oberhausen | |
| Germany | Pathocom - Gemeinschaftspraxis Bischofsstraße Osnabrück | Osnabrück | |
| Germany | Pathologisches Institut Recklinghausen | Recklinghausen | |
| Germany | Klinikum am Steinenberg / Ermstalklinik | Reutlingen | |
| Germany | Diakoniekrankenhaus Institut f.Pathologie | Rotenburg | |
| Germany | Leopoldina Krankenhaus der Stadt Schweinfurt GmbH; Pathologie | Schweinfurt | |
| Germany | HELIOS Klinikum Schwerin; Frauenklinik | Schwerin | |
| Germany | Gemeinschaftspraxis PD Dr.med. Meinald Schultz und Dr.med. Petra Lüders | Stendal | |
| Germany | Robert-Bosch-Krankenhaus; Pathologisches Institut | Stuttgart | |
| Germany | Gemeinschaftspraxis für Pathologie Weiden; am Klinikum Weiden; Giedl, Stelter und Meier | Weiden |
| Lead Sponsor | Collaborator |
|---|---|
| Hoffmann-La Roche |
Germany,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Number of HER2 Positive Samples | 1 day (this is a single time point study) | ||
| Secondary | 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) | ||
| Secondary | Number of HER2 Positive Samples by Sample Extraction (Biopsy versus Resectate) | 1 day (this is a single time point study) | ||
| Secondary | Number of HER2 Positive Samples by Tumor-Node-Metastasis (TNM) Classification | 1 day (this is a single time point study) | ||
| Secondary | Number of HER2 Positive Samples by Sample Source (Primary Tumor, Local Lymph Nodes, Metastasis) | 1 day (this is a single time point study) | ||
| Secondary | Number of HER2 Positive Samples by Applied Method of Tissue Fixation | 1 day (this is a single time point study) | ||
| Secondary | Number of HER2 Positive Samples by Testing Platform | 1 day (this is a single time point study) | ||
| Secondary | Number of HER2 Positive Samples by Automation of Testing | 1 day (this is a single time point study) | ||
| Secondary | Number of HER2 Positive Samples by Antibody Clone Antibody or Test Certification | 1 day (this is a single time point study) | ||
| Secondary | Number of HER2 Positive Samples by Scoring Algorithm | 1 day (this is a single time point study) | ||
| Secondary | Number of HER2 Positive Samples by Round Robin Tests | 1 day (this is a single time point study) | ||
| Secondary | Number of HER2 Positive Samples by Institute's Accreditation | 1 day (this is a single time point study) | ||
| Secondary | Number of HER2 Positive Samples by Institute's Certification | 1 day (this is a single time point study) | ||
| Secondary | Number of HER2 Positive Samples by Tumor Grading | 1 day (this is a single time point study) | ||
| Secondary | Number of HER2 Positive Samples by Participant Age | 1 day (this is a single time point study) | ||
| Secondary | Number of HER2 Positive Samples by Hormone Receptor Status | 1 day (this is a single time point study) |
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