A Study on the Epidemiology and Testing of Human Epidermal Growth Factor-Receptor 2 (HER2) in Breast Cancer in Germany

March 19, 2019 updated by: Hoffmann-La Roche

A Non-interventional Study on the Epidemiology and Testing of HER2 in Breast Cancer in Germany

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

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Anticipated)

15000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Augsburg, Germany, 86156
        • Klinikum Augsburg; Institut für Pathologie
      • Bamberg, Germany, 96049
        • Sozialstiftung Bamberg; Institut für Pathologie
      • Bayreuth, Germany, 95445
        • Klinikum Bayreuth
      • Bergisch Gladbach, Germany, 51465
        • Institut für Pathologie, Zytologie & Molekularpathologie in Bergisch Gladbach
      • Berlin, Germany, 14165
        • HELIOS Klinikum Emil von Behring Klinik f.Pneumologie Onkologie u.Infektiologie
      • Berlin, Germany, 10115
        • Gemeinschaftspraxis für Pathologie Stefan Berger, Jörg Linke und Ellen Fietze
      • Berlin, Germany, 12351
        • Vivantes Klinikum Neukölln; Fachbereich Pathologie
      • Berlin - Spandau, Germany, 13589
        • Gemeinschaftspraxis; Institut für Pathologie am Evangelischen Waldkrankenhaus
      • Bocholt, Germany, 46397
        • Praxis am St. Agnes-Hospital Bocholt
      • Bochum, Germany, 44791
        • Institut für Pathologie und Zytologie an der Augusta-Kranken-Anstalt
      • Bonn, Germany, 53127
        • Universitätsklinikum Bonn; Zentrum für Pathologie Pathologisches Institut
      • Coburg, Germany, 96450
        • Klinikum Coburg GmbH - Institut für Pathologie
      • Dessau-Roßlau, Germany, 06847
        • Städtisches Klinikum Dessau; Institut für Pathologie
      • Dortmund, Germany, 44137
        • Gemeinschaftspraxis für Pathologie Dr. Dykgers, Dr. Langwieder, Dr. Rees
      • Dresden, Germany, 01067
        • Städtisches Klinikum Dresden; Institut für Pathologie "Georg Schmorl" (Friedrichstadt)
      • Duisburg, Germany, 47053
        • Evangelisches Krankenhaus BETHESDA zu Duisburg GmbH; Institut für Pathologie
      • Düren, Germany, 52351
        • Krankenhaus Düren gem. GmbH; Institut und Praxisgemeinschaft für Pathologie
      • Erlangen, Germany, 91054
        • Universitätsklinikum Erlangen; Pathologisches Institut
      • Frankfurt, Germany, 60487
        • OptiPath Gemeinschaftspraxis für Pathologie
      • Freiburg, Germany, 79106
        • Universitätsklinikum Freiburg Institut f.Pathologie
      • Friedrichshafen, Germany, 88048
        • Pathologische Institut Friedrichshafen/Bodensee (Gemeinschaftspraxis für Pathologie und Zytologie)
      • Grevenbroich, Germany, 41515
        • Institut für Pathologie, MVZ am Lukaskrankenhaus
      • Gummersbach, Germany, 51643
        • Klinikum Oberberg; Pathologisches Institut Kreiskrankenhaus Gummersbach
      • Göppingen, Germany, 73035
        • Klinik am Eichert; Institut für Pathologie
      • Göttingen, Germany, 37075
        • Universitätsklinikum Göttingen, Institut für Pathologie
      • Hagen, Germany, 58095
        • Pathologisches Institut am Allg. KH Stadt Hagen; Stambolis, Wolf von Rhüden, Ruwe
      • Halle/Saale, Germany, 06112
        • Universitätsklinikum Halle (Saale), Institut für Pathologie
      • Hamburg, Germany, 22087
        • Kath. Marienkrankenhaus gGmbH
      • Hamburg, Germany, 22547
        • Fachärzte Dres Tiemann & Schulte Partnerschaft; Institut für Hämatopathologie Hamburg
      • Hamm, Germany, 59071
        • Gemeinschaftspraxis für Pathologie Hamm, Dres. Diebold/Niemann
      • Hanau, Germany, 63450
        • Gemeinschaftspraxis Dr. Hartmut Fitz, Dr. Sebastian Blasius und PD Dr. Christian August
      • Hannover, Germany, 30625
        • Medizinische Hochschule Hannover, Klinik für Frauenheilkunde und Geburtshilfe
      • Hannover, Germany, 30175
        • Dres. Wolfgang Beschow Eckehardt Kupsch Herbert Radner u.w.
      • Heidelberg, Germany, 69120
        • Pathologisches Institut
      • Hildesheim, Germany, 31135
        • Institut für Pathologie Hildesheim
      • Ingolstadt, Germany, 85049
        • Gemeinschaftspraxis für Pathologie Ingolstadt Dr. König, Dr. Popp, Prof. Dr. Adam
      • Jena, Germany, 07743
        • Universitätsklinikum Jena; Institut für Pathologie
      • Karlsruhe, Germany, 76113
        • Städtisches Klinikum Karlsruhe gGmbH; Pathologisches Institut
      • Kassel, Germany, 34119
        • Institut Für Pathologie Nordhessen
      • Kassel, Germany, 34125
        • Institut für Pathologie Kassel
      • Kiel, Germany, 24105
        • Institut für Pathologie, Universitäsklinikum Schleswig-Holstein
      • Konstanz, Germany, 78464
        • Klinikum Konstanz gGmbH, Institut und Praxis für Pathologie
      • Köln, Germany, 51109
        • Kliniken der Stadt Köln gGmbH Krankenhaus Merheim
      • Köln, Germany, 50937
        • Institut f. Pathologie, der Univers. Köln
      • Lübeck, Germany, 23552
        • Gemeinschaftspraxis für Pathologie Lübeck; Turzynski, Lebeau, Gocht, Leuenroth
      • Magdeburg, Germany, 39120
        • Universitätsklinikum Magdeburg; Institut für Pathologie und Neuropathologie
      • Magdeburg, Germany, 39130
        • Klinikum Magdeburg GmbH
      • Mannheim, Germany, 68167
        • Klinikum Mannheim; Pathologisches Institut
      • Mühlhausen, Germany, 99974
        • Institut für Pathologie
      • München, Germany, 80992
        • Pathologie München-Nord
      • Münster, Germany, 48149
        • Institut für Pathologie der Universität Münster, Albert Schweitzer Campus, Gebäude D17
      • Münster, Germany, 48153
        • Institut für Pathologie am Clemenshospital Münster
      • Neubrandenburg, Germany, 17022
        • Dietrich Bonhoeffer Kliniken Neubrandenburg, Institut für Pathologie
      • Neuss, Germany, 41462
        • Zentrum für Pathologie, Zytologie und Molekularpathologie Neuss
      • Oberhausen, Germany, 46047
        • Evangelisches Krankenhaus Oberhausen GmbH, Institut f.Pathologie
      • Osnabrück, Germany, 49074
        • Pathocom - Gemeinschaftspraxis Bischofsstraße Osnabrück
      • Recklinghausen, Germany, 45659
        • Pathologisches Institut Recklinghausen
      • Reutlingen, Germany, 72764
        • Klinikum am Steinenberg / Ermstalklinik
      • Rotenburg, Germany, 27356
        • Diakoniekrankenhaus Institut f.Pathologie
      • Schweinfurt, Germany, 97422
        • Leopoldina Krankenhaus der Stadt Schweinfurt GmbH; Pathologie
      • Schwerin, Germany, 19049
        • HELIOS Klinikum Schwerin; Frauenklinik
      • Stendal, Germany, 39576
        • Gemeinschaftspraxis PD Dr.med. Meinald Schultz und Dr.med. Petra Lüders
      • Stuttgart, Germany, 70376
        • Robert-Bosch-Krankenhaus; Pathologisches Institut
      • Weiden, Germany, 92637
        • Gemeinschaftspraxis für Pathologie Weiden; am Klinikum Weiden; Giedl, Stelter und Meier

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Breast cancer tissue samples from participants in Germany

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Breast Cancer Pathology Samples
Data on the epidemiology and HER2 testing of breast cancer will be collected from pathology routine diagnostics.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of HER2 Positive Samples
Time Frame: 1 day (this is a single time point study)
1 day (this is a single time point study)

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of HER2 Positive Samples by Carcinoma Subtype (No Special Type\Ductal, Lobular, Other Special Type)
Time Frame: 1 day (this is a single time point study)
1 day (this is a single time point study)
Number of HER2 Positive Samples by Sample Extraction (Biopsy versus Resectate)
Time Frame: 1 day (this is a single time point study)
1 day (this is a single time point study)
Number of HER2 Positive Samples by Tumor-Node-Metastasis (TNM) Classification
Time Frame: 1 day (this is a single time point study)
1 day (this is a single time point study)
Number of HER2 Positive Samples by Sample Source (Primary Tumor, Local Lymph Nodes, Metastasis)
Time Frame: 1 day (this is a single time point study)
1 day (this is a single time point study)
Number of HER2 Positive Samples by Applied Method of Tissue Fixation
Time Frame: 1 day (this is a single time point study)
1 day (this is a single time point study)
Number of HER2 Positive Samples by Testing Platform
Time Frame: 1 day (this is a single time point study)
1 day (this is a single time point study)
Number of HER2 Positive Samples by Automation of Testing
Time Frame: 1 day (this is a single time point study)
1 day (this is a single time point study)
Number of HER2 Positive Samples by Antibody Clone Antibody or Test Certification
Time Frame: 1 day (this is a single time point study)
1 day (this is a single time point study)
Number of HER2 Positive Samples by Scoring Algorithm
Time Frame: 1 day (this is a single time point study)
1 day (this is a single time point study)
Number of HER2 Positive Samples by Round Robin Tests
Time Frame: 1 day (this is a single time point study)
1 day (this is a single time point study)
Number of HER2 Positive Samples by Institute's Accreditation
Time Frame: 1 day (this is a single time point study)
1 day (this is a single time point study)
Number of HER2 Positive Samples by Institute's Certification
Time Frame: 1 day (this is a single time point study)
1 day (this is a single time point study)
Number of HER2 Positive Samples by Tumor Grading
Time Frame: 1 day (this is a single time point study)
1 day (this is a single time point study)
Number of HER2 Positive Samples by Participant Age
Time Frame: 1 day (this is a single time point study)
1 day (this is a single time point study)
Number of HER2 Positive Samples by Hormone Receptor Status
Time Frame: 1 day (this is a single time point study)
1 day (this is a single time point study)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hoffmann-La Roche

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 4, 2016

Primary Completion (Actual)

February 28, 2018

Study Completion (Actual)

February 28, 2018

Study Registration Dates

First Submitted

January 11, 2016

First Submitted That Met QC Criteria

January 25, 2016

First Posted (Estimate)

January 28, 2016

Study Record Updates

Last Update Posted (Actual)

March 21, 2019

Last Update Submitted That Met QC Criteria

March 19, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ML29763

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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