Clinical trial NCT02666261: A Study on the Epidemiology and Testing of Human Epidermal Growth Factor-Receptor 2 (HER2) in Breast Cancer in Germany
Official title: A Non-interventional Study on the Epidemiology and Testing of HER2 in Breast Cancer in Germany
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2016-01-28
Enrollment: 15000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Breast cancer tissue samples from participants in Germany

Brief summary: This non-interventional study will collect data from routine diagnostics on HER2 testing of breast cancer in Germany.


Eligibility criteria: 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.

Primary outcomes:
measure: Number of HER2 Positive Samples
timeFrame: 1 day (this is a single time point study)
Secondary outcomes:
measure: Number of HER2 Positive Samples by Carcinoma Subtype (No Special Type\Ductal, Lobular, Other Special Type)
timeFrame: 1 day (this is a single time point study)
measure: Number of HER2 Positive Samples by Sample Extraction (Biopsy versus Resectate)
timeFrame: 1 day (this is a single time point study)
measure: Number of HER2 Positive Samples by Tumor-Node-Metastasis (TNM) Classification
timeFrame: 1 day (this is a single time point study)
measure: Number of HER2 Positive Samples by Sample Source (Primary Tumor, Local Lymph Nodes, Metastasis)
timeFrame: 1 day (this is a single time point study)
measure: Number of HER2 Positive Samples by Applied Method of Tissue Fixation
timeFrame: 1 day (this is a single time point study)
measure: Number of HER2 Positive Samples by Testing Platform
timeFrame: 1 day (this is a single time point study)
measure: Number of HER2 Positive Samples by Automation of Testing
timeFrame: 1 day (this is a single time point study)
measure: Number of HER2 Positive Samples by Antibody Clone Antibody or Test Certification
timeFrame: 1 day (this is a single time point study)
measure: Number of HER2 Positive Samples by Scoring Algorithm
timeFrame: 1 day (this is a single time point study)
measure: Number of HER2 Positive Samples by Round Robin Tests
timeFrame: 1 day (this is a single time point study)
measure: Number of HER2 Positive Samples by Institute's Accreditation
timeFrame: 1 day (this is a single time point study)
measure: Number of HER2 Positive Samples by Institute's Certification
timeFrame: 1 day (this is a single time point study)
measure: Number of HER2 Positive Samples by Tumor Grading
timeFrame: 1 day (this is a single time point study)
measure: Number of HER2 Positive Samples by Participant Age
timeFrame: 1 day (this is a single time point study)
measure: Number of HER2 Positive Samples by Hormone Receptor Status
timeFrame: 1 day (this is a single time point study)
Other outcomes:
Locations:
city: Augsburg
country: Germany
facility: Klinikum Augsburg; Institut für Pathologie
city: Bamberg
country: Germany
facility: Sozialstiftung Bamberg; Institut für Pathologie
city: Bayreuth
country: Germany
facility: Klinikum Bayreuth
city: Bergisch Gladbach
country: Germany
facility: Institut für Pathologie, Zytologie & Molekularpathologie in Bergisch Gladbach
city: Berlin - Spandau
country: Germany
facility: Gemeinschaftspraxis; Institut für Pathologie am Evangelischen Waldkrankenhaus
city: Berlin
country: Germany
facility: Gemeinschaftspraxis für Pathologie Stefan Berger, Jörg Linke und Ellen Fietze
city: Berlin
country: Germany
facility: Vivantes Klinikum Neukölln; Fachbereich Pathologie
city: Berlin
country: Germany
facility: HELIOS Klinikum Emil von Behring Klinik f.Pneumologie Onkologie u.Infektiologie
city: Bocholt
country: Germany
facility: Praxis am St. Agnes-Hospital Bocholt
city: Bochum
country: Germany
facility: Institut für Pathologie und Zytologie an der Augusta-Kranken-Anstalt
city: Bonn
country: Germany
facility: Universitätsklinikum Bonn; Zentrum für Pathologie Pathologisches Institut
city: Coburg
country: Germany
facility: Klinikum Coburg GmbH - Institut für Pathologie
city: Dessau-Roßlau
country: Germany
facility: Städtisches Klinikum Dessau; Institut für Pathologie
city: Dortmund
country: Germany
facility: Gemeinschaftspraxis für Pathologie Dr. Dykgers, Dr. Langwieder, Dr. Rees
city: Dresden
country: Germany
facility: Städtisches Klinikum Dresden; Institut für Pathologie "Georg Schmorl" (Friedrichstadt)
city: Duisburg
country: Germany
facility: Evangelisches Krankenhaus BETHESDA zu Duisburg GmbH; Institut für Pathologie
city: Düren
country: Germany
facility: Krankenhaus Düren gem. GmbH; Institut und Praxisgemeinschaft für Pathologie
city: Erlangen
country: Germany
facility: Universitätsklinikum Erlangen; Pathologisches Institut
city: Frankfurt
country: Germany
facility: OptiPath Gemeinschaftspraxis für Pathologie
city: Freiburg
country: Germany
facility: Universitätsklinikum Freiburg Institut f.Pathologie
city: Friedrichshafen
country: Germany
facility: Pathologische Institut Friedrichshafen/Bodensee (Gemeinschaftspraxis für Pathologie und Zytologie)
city: Grevenbroich
country: Germany
facility: Institut für Pathologie, MVZ am Lukaskrankenhaus
city: Gummersbach
country: Germany
facility: Klinikum Oberberg; Pathologisches Institut Kreiskrankenhaus Gummersbach
city: Göppingen
country: Germany
facility: Klinik am Eichert; Institut für Pathologie
city: Göttingen
country: Germany
facility: Universitätsklinikum Göttingen, Institut für Pathologie
city: Hagen
country: Germany
facility: Pathologisches Institut am Allg. KH Stadt Hagen; Stambolis, Wolf von Rhüden, Ruwe
city: Halle/Saale
country: Germany
facility: Universitätsklinikum Halle (Saale), Institut für Pathologie
city: Hamburg
country: Germany
facility: Kath. Marienkrankenhaus gGmbH
city: Hamburg
country: Germany
facility: Fachärzte Dres Tiemann & Schulte Partnerschaft; Institut für Hämatopathologie Hamburg
city: Hamm
country: Germany
facility: Gemeinschaftspraxis für Pathologie Hamm, Dres. Diebold/Niemann
city: Hanau
country: Germany
facility: Gemeinschaftspraxis Dr. Hartmut Fitz, Dr. Sebastian Blasius und PD Dr. Christian August
city: Hannover
country: Germany
facility: Dres. Wolfgang Beschow Eckehardt Kupsch Herbert Radner u.w.
city: Hannover
country: Germany
facility: Medizinische Hochschule Hannover, Klinik für Frauenheilkunde und Geburtshilfe
city: Heidelberg
country: Germany
facility: Pathologisches Institut
city: Hildesheim
country: Germany
facility: Institut für Pathologie Hildesheim
city: Ingolstadt
country: Germany
facility: Gemeinschaftspraxis für Pathologie Ingolstadt Dr. König, Dr. Popp, Prof. Dr. Adam
city: Jena
country: Germany
facility: Universitätsklinikum Jena; Institut für Pathologie
city: Karlsruhe
country: Germany
facility: Städtisches Klinikum Karlsruhe gGmbH; Pathologisches Institut
city: Kassel
country: Germany
facility: Institut Für Pathologie Nordhessen
city: Kassel
country: Germany
facility: Institut für Pathologie Kassel
city: Kiel
country: Germany
facility: Institut für Pathologie, Universitäsklinikum Schleswig-Holstein
city: Konstanz
country: Germany
facility: Klinikum Konstanz gGmbH, Institut und Praxis für Pathologie
city: Köln
country: Germany
facility: Institut f. Pathologie, der Univers. Köln
city: Köln
country: Germany
facility: Kliniken der Stadt Köln gGmbH Krankenhaus Merheim
city: Lübeck
country: Germany
facility: Gemeinschaftspraxis für Pathologie Lübeck; Turzynski, Lebeau, Gocht, Leuenroth
city: Magdeburg
country: Germany
facility: Universitätsklinikum Magdeburg; Institut für Pathologie und Neuropathologie
city: Magdeburg
country: Germany
facility: Klinikum Magdeburg GmbH
city: Mannheim
country: Germany
facility: Klinikum Mannheim; Pathologisches Institut
city: Mühlhausen
country: Germany
facility: Institut für Pathologie
city: München
country: Germany
facility: Pathologie München-Nord
city: Münster
country: Germany
facility: Institut für Pathologie der Universität Münster, Albert Schweitzer Campus, Gebäude D17
city: Münster
country: Germany
facility: Institut für Pathologie am Clemenshospital Münster
city: Neubrandenburg
country: Germany
facility: Dietrich Bonhoeffer Kliniken Neubrandenburg, Institut für Pathologie
city: Neuss
country: Germany
facility: Zentrum für Pathologie, Zytologie und Molekularpathologie Neuss
city: Oberhausen
country: Germany
facility: Evangelisches Krankenhaus Oberhausen GmbH, Institut f.Pathologie
city: Osnabrück
country: Germany
facility: Pathocom - Gemeinschaftspraxis Bischofsstraße Osnabrück
city: Recklinghausen
country: Germany
facility: Pathologisches Institut Recklinghausen
city: Reutlingen
country: Germany
facility: Klinikum am Steinenberg / Ermstalklinik
city: Rotenburg
country: Germany
facility: Diakoniekrankenhaus Institut f.Pathologie
city: Schweinfurt
country: Germany
facility: Leopoldina Krankenhaus der Stadt Schweinfurt GmbH; Pathologie
city: Schwerin
country: Germany
facility: HELIOS Klinikum Schwerin; Frauenklinik
city: Stendal
country: Germany
facility: Gemeinschaftspraxis PD Dr.med. Meinald Schultz und Dr.med. Petra Lüders
city: Stuttgart
country: Germany
facility: Robert-Bosch-Krankenhaus; Pathologisches Institut
city: Weiden
country: Germany
facility: Gemeinschaftspraxis für Pathologie Weiden; am Klinikum Weiden; Giedl, Stelter und Meier
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: