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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 4, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 28, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 28, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 11, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 25, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 28, 2016

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 21, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 19, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings