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

NCT02666261 | Completed

• 1 other identifier: ML29763
• Study Type: observational
• Target: 15,000
• Locations: 1 country
• Sites: 64

Brief Summary

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

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Number of HER2 Positive Samples

  1 day (this is a single time point study)

Secondary Outcomes (15)

• 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 Tumor-Node-Metastasis (TNM) Classification

  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 Applied Method of Tissue Fixation

  1 day (this is a single time point study)

Study Arms (1)

Breast Cancer Pathology Samples

Data on the epidemiology and HER2 testing of breast cancer will be collected from pathology routine diagnostics.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Breast cancer tissue samples from participants in Germany

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (64)

Klinikum Augsburg; Institut für Pathologie

Augsburg, 86156, Germany

Location

Sozialstiftung Bamberg; Institut für Pathologie

Bamberg, 96049, Germany

Location

Klinikum Bayreuth

Bayreuth, 95445, Germany

Location

Institut für Pathologie, Zytologie & Molekularpathologie in Bergisch Gladbach

Bergisch Gladbach, 51465, Germany

Location

Gemeinschaftspraxis für Pathologie Stefan Berger, Jörg Linke und Ellen Fietze

Berlin, 10115, Germany

Location

Vivantes Klinikum Neukölln; Fachbereich Pathologie

Berlin, 12351, Germany

Location

HELIOS Klinikum Emil von Behring Klinik f.Pneumologie Onkologie u.Infektiologie

Berlin, 14165, Germany

Location

Gemeinschaftspraxis; Institut für Pathologie am Evangelischen Waldkrankenhaus

Berlin - Spandau, 13589, Germany

Location

Praxis am St. Agnes-Hospital Bocholt

Bocholt, 46397, Germany

Location

Institut für Pathologie und Zytologie an der Augusta-Kranken-Anstalt

Bochum, 44791, Germany

Location

Universitätsklinikum Bonn; Zentrum für Pathologie Pathologisches Institut

Bonn, 53127, Germany

Location

Klinikum Coburg GmbH - Institut für Pathologie

Coburg, 96450, Germany

Location

Institut f. Pathologie, der Univers. Köln

Cologne, 50937, Germany

Location

Kliniken der Stadt Köln gGmbH Krankenhaus Merheim

Cologne, 51109, Germany

Location

Städtisches Klinikum Dessau; Institut für Pathologie

Dessau, 06847, Germany

Location

Gemeinschaftspraxis für Pathologie Dr. Dykgers, Dr. Langwieder, Dr. Rees

Dortmund, 44137, Germany

Location

Städtisches Klinikum Dresden; Institut für Pathologie "Georg Schmorl" (Friedrichstadt)

Dresden, 01067, Germany

Location

Evangelisches Krankenhaus BETHESDA zu Duisburg GmbH; Institut für Pathologie

Duisburg, 47053, Germany

Location

Krankenhaus Düren gem. GmbH; Institut und Praxisgemeinschaft für Pathologie

Düren, 52351, Germany

Location

Universitätsklinikum Erlangen; Pathologisches Institut

Erlangen, 91054, Germany

Location

OptiPath Gemeinschaftspraxis für Pathologie

Frankfurt, 60487, Germany

Location

Universitätsklinikum Freiburg Institut f.Pathologie

Freiburg im Breisgau, 79106, Germany

Location

Pathologische Institut Friedrichshafen/Bodensee (Gemeinschaftspraxis für Pathologie und Zytologie)

Friedrichshafen, 88048, Germany

Location

Klinik am Eichert; Institut für Pathologie

Göppingen, 73035, Germany

Location

Universitätsklinikum Göttingen, Institut für Pathologie

Göttingen, 37075, Germany

Location

Institut für Pathologie, MVZ am Lukaskrankenhaus

Grevenbroich, 41515, Germany

Location

Klinikum Oberberg; Pathologisches Institut Kreiskrankenhaus Gummersbach

Gummersbach, 51643, Germany

Location

Pathologisches Institut am Allg. KH Stadt Hagen; Stambolis, Wolf von Rhüden, Ruwe

Hagen, 58095, Germany

Location

Universitätsklinikum Halle (Saale), Institut für Pathologie

Halle, 06112, Germany

Location

Kath. Marienkrankenhaus gGmbH

Hamburg, 22087, Germany

Location

Fachärzte Dres Tiemann & Schulte Partnerschaft; Institut für Hämatopathologie Hamburg

Hamburg, 22547, Germany

Location

Gemeinschaftspraxis für Pathologie Hamm, Dres. Diebold/Niemann

Hamm, 59071, Germany

Location

Gemeinschaftspraxis Dr. Hartmut Fitz, Dr. Sebastian Blasius und PD Dr. Christian August

Hanau, 63450, Germany

Location

Dres. Wolfgang Beschow Eckehardt Kupsch Herbert Radner u.w.

Hanover, 30175, Germany

Location

Medizinische Hochschule Hannover, Klinik für Frauenheilkunde und Geburtshilfe

Hanover, 30625, Germany

Location

Pathologisches Institut

Heidelberg, 69120, Germany

Location

Institut für Pathologie Hildesheim

Hildesheim, 31135, Germany

Location

Gemeinschaftspraxis für Pathologie Ingolstadt Dr. König, Dr. Popp, Prof. Dr. Adam

Ingolstadt, 85049, Germany

Location

Universitätsklinikum Jena; Institut für Pathologie

Jena, 07743, Germany

Location

Städtisches Klinikum Karlsruhe gGmbH; Pathologisches Institut

Karlsruhe, 76113, Germany

Location

Institut Für Pathologie Nordhessen

Kassel, 34119, Germany

Location

Institut für Pathologie Kassel

Kassel, 34125, Germany

Location

Institut für Pathologie, Universitäsklinikum Schleswig-Holstein

Kiel, 24105, Germany

Location

Klinikum Konstanz gGmbH, Institut und Praxis für Pathologie

Konstanz, 78464, Germany

Location

Gemeinschaftspraxis für Pathologie Lübeck; Turzynski, Lebeau, Gocht, Leuenroth

Lübeck, 23552, Germany

Location

Universitätsklinikum Magdeburg; Institut für Pathologie und Neuropathologie

Magdeburg, 39120, Germany

Location

Klinikum Magdeburg GmbH

Magdeburg, 39130, Germany

Location

Klinikum Mannheim; Pathologisches Institut

Mannheim, 68167, Germany

Location

Institut für Pathologie

Mühlhausen, 99974, Germany

Location

Pathologie München-Nord

München, 80992, Germany

Location

Institut für Pathologie der Universität Münster, Albert Schweitzer Campus, Gebäude D17

Münster, 48149, Germany

Location

Institut für Pathologie am Clemenshospital Münster

Münster, 48153, Germany

Location

Dietrich Bonhoeffer Kliniken Neubrandenburg, Institut für Pathologie

Neubrandenburg, 17022, Germany

Location

Zentrum für Pathologie, Zytologie und Molekularpathologie Neuss

Neuss, 41462, Germany

Location

Evangelisches Krankenhaus Oberhausen GmbH, Institut f.Pathologie

Oberhausen, 46047, Germany

Location

Pathocom - Gemeinschaftspraxis Bischofsstraße Osnabrück

Osnabrück, 49074, Germany

Location

Pathologisches Institut Recklinghausen

Recklinghausen, 45659, Germany

Location

Klinikum am Steinenberg / Ermstalklinik

Reutlingen, 72764, Germany

Location

Diakoniekrankenhaus Institut f.Pathologie

Rotenburg (Wümme), 27356, Germany

Location

Leopoldina Krankenhaus der Stadt Schweinfurt GmbH; Pathologie

Schweinfurt, 97422, Germany

Location

HELIOS Klinikum Schwerin; Frauenklinik

Schwerin, 19049, Germany

Location

Gemeinschaftspraxis PD Dr.med. Meinald Schultz und Dr.med. Petra Lüders

Stendal, 39576, Germany

Location

Robert-Bosch-Krankenhaus; Pathologisches Institut

Stuttgart, 70376, Germany

Location

Gemeinschaftspraxis für Pathologie Weiden; am Klinikum Weiden; Giedl, Stelter und Meier

Weiden, 92637, Germany

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 11, 2016
• First Posted: January 28, 2016
• Study Start: March 4, 2016
• Primary Completion: February 28, 2018
• Study Completion: February 28, 2018
• Last Updated: March 21, 2019

Record last verified: 2019-03

Locations

DE (64)