Ignite Creation Date:
2025-12-24 @ 12:46 PM
Ignite Modification Date:
2026-01-27 @ 3:23 AM
Study NCT ID:
NCT02666261
Status:
COMPLETED
Last Update Posted:
2019-03-21
First Post:
2016-01-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study on the Epidemiology and Testing of Human Epidermal Growth Factor-Receptor 2 (HER2) in Breast Cancer in Germany
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 15000}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-03-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-03', 'completionDateStruct': {'date': '2018-02-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-03-19', 'studyFirstSubmitDate': '2016-01-11', 'studyFirstSubmitQcDate': '2016-01-25', 'lastUpdatePostDateStruct': {'date': '2019-03-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-01-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-02-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of HER2 Positive Samples', 'timeFrame': '1 day (this is a single time point study)'}], 'secondaryOutcomes': [{'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)'}]}, 'conditionsModule': {'conditions': ['Breast Cancer']}, 'descriptionModule': {'briefSummary': 'This non-interventional study will collect data from routine diagnostics on HER2 testing of breast cancer in Germany.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Breast cancer tissue samples from participants in Germany', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Samples derived from men and women of age greater than or equal to (\\>/=) 18 years\n* Samples derived from participants with any stage of histologically confirmed invasive breast cancer with HER2 diagnostics performed within routine (histo-)pathological workup or\n* (Histo-)Pathological work-up of the tumor sample as at or after start of this study\n* Available information on the year of birth of the participant\n* No pre-selection of tumor samples is allowed. Tumor samples have to be documented consecutively in the order of their (histo-)pathological work-up.\n\nExclusion Criteria:\n\n* Sample derived from participants with any stage of breast cancer with no HER2 diagnostics performed at the time of routine (histo-)pathological work-up.\n* Samples derived prior to the start of this study.'}, 'identificationModule': {'nctId': 'NCT02666261', 'briefTitle': 'A Study on the Epidemiology and Testing of Human Epidermal Growth Factor-Receptor 2 (HER2) in Breast Cancer in Germany', 'organization': {'class': 'INDUSTRY', 'fullName': 'Hoffmann-La Roche'}, 'officialTitle': 'A Non-interventional Study on the Epidemiology and Testing of HER2 in Breast Cancer in Germany', 'orgStudyIdInfo': {'id': 'ML29763'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Breast Cancer Pathology Samples', 'description': 'Data on the epidemiology and HER2 testing of breast cancer will be collected from pathology routine diagnostics.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '86156', 'city': 'Augsburg', 'country': 'Germany', 'facility': 'Klinikum Augsburg; Institut für Pathologie', 'geoPoint': {'lat': 48.37154, 'lon': 10.89851}}, {'zip': '96049', 'city': 'Bamberg', 'country': 'Germany', 'facility': 'Sozialstiftung Bamberg; Institut für Pathologie', 'geoPoint': {'lat': 49.89873, 'lon': 10.90067}}, {'zip': '95445', 'city': 'Bayreuth', 'country': 'Germany', 'facility': 'Klinikum Bayreuth', 'geoPoint': {'lat': 49.94782, 'lon': 11.57893}}, {'zip': '51465', 'city': 'Bergisch Gladbach', 'country': 'Germany', 'facility': 'Institut für Pathologie, Zytologie & Molekularpathologie in Bergisch Gladbach', 'geoPoint': {'lat': 50.9856, 'lon': 7.13298}}, {'zip': '10115', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Gemeinschaftspraxis für Pathologie Stefan Berger, Jörg Linke und Ellen Fietze', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '12351', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Vivantes Klinikum Neukölln; Fachbereich Pathologie', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '14165', 'city': 'Berlin', 'country': 'Germany', 'facility': 'HELIOS Klinikum Emil von Behring Klinik f.Pneumologie Onkologie u.Infektiologie', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '13589', 'city': 'Berlin - Spandau', 'country': 'Germany', 'facility': 'Gemeinschaftspraxis; Institut für Pathologie am Evangelischen Waldkrankenhaus'}, {'zip': '46397', 'city': 'Bocholt', 'country': 'Germany', 'facility': 'Praxis am St. Agnes-Hospital Bocholt', 'geoPoint': {'lat': 51.83879, 'lon': 6.61531}}, {'zip': '44791', 'city': 'Bochum', 'country': 'Germany', 'facility': 'Institut für Pathologie und Zytologie an der Augusta-Kranken-Anstalt', 'geoPoint': {'lat': 51.48165, 'lon': 7.21648}}, {'zip': '53127', 'city': 'Bonn', 'country': 'Germany', 'facility': 'Universitätsklinikum Bonn; Zentrum für Pathologie Pathologisches Institut', 'geoPoint': {'lat': 50.73438, 'lon': 7.09549}}, {'zip': '96450', 'city': 'Coburg', 'country': 'Germany', 'facility': 'Klinikum Coburg GmbH - Institut für Pathologie', 'geoPoint': {'lat': 50.25937, 'lon': 10.96384}}, {'zip': '50937', 'city': 'Cologne', 'country': 'Germany', 'facility': 'Institut f. Pathologie, der Univers. Köln', 'geoPoint': {'lat': 50.93333, 'lon': 6.95}}, {'zip': '51109', 'city': 'Cologne', 'country': 'Germany', 'facility': 'Kliniken der Stadt Köln gGmbH Krankenhaus Merheim', 'geoPoint': {'lat': 50.93333, 'lon': 6.95}}, {'zip': '06847', 'city': 'Dessau', 'country': 'Germany', 'facility': 'Städtisches Klinikum Dessau; Institut für Pathologie', 'geoPoint': {'lat': 51.83864, 'lon': 12.24555}}, {'zip': '44137', 'city': 'Dortmund', 'country': 'Germany', 'facility': 'Gemeinschaftspraxis für Pathologie Dr. Dykgers, Dr. Langwieder, Dr. Rees', 'geoPoint': {'lat': 51.51494, 'lon': 7.466}}, {'zip': '01067', 'city': 'Dresden', 'country': 'Germany', 'facility': 'Städtisches Klinikum Dresden; Institut für Pathologie "Georg Schmorl" (Friedrichstadt)', 'geoPoint': {'lat': 51.05089, 'lon': 13.73832}}, {'zip': '47053', 'city': 'Duisburg', 'country': 'Germany', 'facility': 'Evangelisches Krankenhaus BETHESDA zu Duisburg GmbH; Institut für Pathologie', 'geoPoint': {'lat': 51.43247, 'lon': 6.76516}}, {'zip': '52351', 'city': 'Düren', 'country': 'Germany', 'facility': 'Krankenhaus Düren gem. GmbH; Institut und Praxisgemeinschaft für Pathologie', 'geoPoint': {'lat': 50.80434, 'lon': 6.49299}}, {'zip': '91054', 'city': 'Erlangen', 'country': 'Germany', 'facility': 'Universitätsklinikum Erlangen; Pathologisches Institut', 'geoPoint': {'lat': 49.59099, 'lon': 11.00783}}, {'zip': '60487', 'city': 'Frankfurt', 'country': 'Germany', 'facility': 'OptiPath Gemeinschaftspraxis für Pathologie', 'geoPoint': {'lat': 49.68333, 'lon': 10.53333}}, {'zip': '79106', 'city': 'Freiburg im Breisgau', 'country': 'Germany', 'facility': 'Universitätsklinikum Freiburg Institut f.Pathologie', 'geoPoint': {'lat': 47.9959, 'lon': 7.85222}}, {'zip': '88048', 'city': 'Friedrichshafen', 'country': 'Germany', 'facility': 'Pathologische Institut Friedrichshafen/Bodensee (Gemeinschaftspraxis für Pathologie und Zytologie)', 'geoPoint': {'lat': 47.65689, 'lon': 9.47554}}, {'zip': '73035', 'city': 'Göppingen', 'country': 'Germany', 'facility': 'Klinik am Eichert; Institut für Pathologie', 'geoPoint': {'lat': 48.70354, 'lon': 9.65209}}, {'zip': '37075', 'city': 'Göttingen', 'country': 'Germany', 'facility': 'Universitätsklinikum Göttingen, Institut für Pathologie', 'geoPoint': {'lat': 51.53443, 'lon': 9.93228}}, {'zip': '41515', 'city': 'Grevenbroich', 'country': 'Germany', 'facility': 'Institut für Pathologie, MVZ am Lukaskrankenhaus', 'geoPoint': {'lat': 51.09102, 'lon': 6.5827}}, {'zip': '51643', 'city': 'Gummersbach', 'country': 'Germany', 'facility': 'Klinikum Oberberg; Pathologisches Institut Kreiskrankenhaus Gummersbach', 'geoPoint': {'lat': 51.02608, 'lon': 7.56473}}, {'zip': '58095', 'city': 'Hagen', 'country': 'Germany', 'facility': 'Pathologisches Institut am Allg. KH Stadt Hagen; Stambolis, Wolf von Rhüden, Ruwe', 'geoPoint': {'lat': 51.36081, 'lon': 7.47168}}, {'zip': '06112', 'city': 'Halle', 'country': 'Germany', 'facility': 'Universitätsklinikum Halle (Saale), Institut für Pathologie', 'geoPoint': {'lat': 51.48158, 'lon': 11.97947}}, {'zip': '22087', 'city': 'Hamburg', 'country': 'Germany', 'facility': 'Kath. Marienkrankenhaus gGmbH', 'geoPoint': {'lat': 53.55073, 'lon': 9.99302}}, {'zip': '22547', 'city': 'Hamburg', 'country': 'Germany', 'facility': 'Fachärzte Dres Tiemann & Schulte Partnerschaft; Institut für Hämatopathologie Hamburg', 'geoPoint': {'lat': 53.55073, 'lon': 9.99302}}, {'zip': '59071', 'city': 'Hamm', 'country': 'Germany', 'facility': 'Gemeinschaftspraxis für Pathologie Hamm, Dres. Diebold/Niemann', 'geoPoint': {'lat': 51.68033, 'lon': 7.82089}}, {'zip': '63450', 'city': 'Hanau', 'country': 'Germany', 'facility': 'Gemeinschaftspraxis Dr. Hartmut Fitz, Dr. Sebastian Blasius und PD Dr. Christian August', 'geoPoint': {'lat': 50.13423, 'lon': 8.91418}}, {'zip': '30175', 'city': 'Hanover', 'country': 'Germany', 'facility': 'Dres. Wolfgang Beschow Eckehardt Kupsch Herbert Radner u.w.', 'geoPoint': {'lat': 52.37052, 'lon': 9.73322}}, {'zip': '30625', 'city': 'Hanover', 'country': 'Germany', 'facility': 'Medizinische Hochschule Hannover, Klinik für Frauenheilkunde und Geburtshilfe', 'geoPoint': {'lat': 52.37052, 'lon': 9.73322}}, {'zip': '69120', 'city': 'Heidelberg', 'country': 'Germany', 'facility': 'Pathologisches Institut', 'geoPoint': {'lat': 49.40768, 'lon': 8.69079}}, {'zip': '31135', 'city': 'Hildesheim', 'country': 'Germany', 'facility': 'Institut für Pathologie Hildesheim', 'geoPoint': {'lat': 52.15077, 'lon': 9.95112}}, {'zip': '85049', 'city': 'Ingolstadt', 'country': 'Germany', 'facility': 'Gemeinschaftspraxis für Pathologie Ingolstadt Dr. König, Dr. Popp, Prof. Dr. Adam', 'geoPoint': {'lat': 48.76508, 'lon': 11.42372}}, {'zip': '07743', 'city': 'Jena', 'country': 'Germany', 'facility': 'Universitätsklinikum Jena; Institut für Pathologie', 'geoPoint': {'lat': 50.92878, 'lon': 11.5899}}, {'zip': '76113', 'city': 'Karlsruhe', 'country': 'Germany', 'facility': 'Städtisches Klinikum Karlsruhe gGmbH; Pathologisches Institut', 'geoPoint': {'lat': 49.00937, 'lon': 8.40444}}, {'zip': '34119', 'city': 'Kassel', 'country': 'Germany', 'facility': 'Institut Für Pathologie Nordhessen', 'geoPoint': {'lat': 51.31667, 'lon': 9.5}}, {'zip': '34125', 'city': 'Kassel', 'country': 'Germany', 'facility': 'Institut für Pathologie Kassel', 'geoPoint': {'lat': 51.31667, 'lon': 9.5}}, {'zip': '24105', 'city': 'Kiel', 'country': 'Germany', 'facility': 'Institut für Pathologie, Universitäsklinikum Schleswig-Holstein', 'geoPoint': {'lat': 54.32133, 'lon': 10.13489}}, {'zip': '78464', 'city': 'Konstanz', 'country': 'Germany', 'facility': 'Klinikum Konstanz gGmbH, Institut und Praxis für Pathologie', 'geoPoint': {'lat': 47.66033, 'lon': 9.17582}}, {'zip': '23552', 'city': 'Lübeck', 'country': 'Germany', 'facility': 'Gemeinschaftspraxis für Pathologie Lübeck; Turzynski, Lebeau, Gocht, Leuenroth', 'geoPoint': {'lat': 53.86893, 'lon': 10.68729}}, {'zip': '39120', 'city': 'Magdeburg', 'country': 'Germany', 'facility': 'Universitätsklinikum Magdeburg; Institut für Pathologie und Neuropathologie', 'geoPoint': {'lat': 52.13129, 'lon': 11.63189}}, {'zip': '39130', 'city': 'Magdeburg', 'country': 'Germany', 'facility': 'Klinikum Magdeburg GmbH', 'geoPoint': {'lat': 52.13129, 'lon': 11.63189}}, {'zip': '68167', 'city': 'Mannheim', 'country': 'Germany', 'facility': 'Klinikum Mannheim; Pathologisches Institut', 'geoPoint': {'lat': 49.4891, 'lon': 8.46694}}, {'zip': '99974', 'city': 'Mühlhausen', 'country': 'Germany', 'facility': 'Institut für Pathologie', 'geoPoint': {'lat': 51.20896, 'lon': 10.45275}}, {'zip': '80992', 'city': 'München', 'country': 'Germany', 'facility': 'Pathologie München-Nord', 'geoPoint': {'lat': 51.60698, 'lon': 13.31243}}, {'zip': '48149', 'city': 'Münster', 'country': 'Germany', 'facility': 'Institut für Pathologie der Universität Münster, Albert Schweitzer Campus, Gebäude D17', 'geoPoint': {'lat': 51.96236, 'lon': 7.62571}}, {'zip': '48153', 'city': 'Münster', 'country': 'Germany', 'facility': 'Institut für Pathologie am Clemenshospital Münster', 'geoPoint': {'lat': 51.96236, 'lon': 7.62571}}, {'zip': '17022', 'city': 'Neubrandenburg', 'country': 'Germany', 'facility': 'Dietrich Bonhoeffer Kliniken Neubrandenburg, Institut für Pathologie', 'geoPoint': {'lat': 53.55735, 'lon': 13.26105}}, {'zip': '41462', 'city': 'Neuss', 'country': 'Germany', 'facility': 'Zentrum für Pathologie, Zytologie und Molekularpathologie Neuss', 'geoPoint': {'lat': 51.19807, 'lon': 6.68504}}, {'zip': '46047', 'city': 'Oberhausen', 'country': 'Germany', 'facility': 'Evangelisches Krankenhaus Oberhausen GmbH, Institut f.Pathologie', 'geoPoint': {'lat': 51.47805, 'lon': 6.8625}}, {'zip': '49074', 'city': 'Osnabrück', 'country': 'Germany', 'facility': 'Pathocom - Gemeinschaftspraxis Bischofsstraße Osnabrück', 'geoPoint': {'lat': 52.27264, 'lon': 8.0498}}, {'zip': '45659', 'city': 'Recklinghausen', 'country': 'Germany', 'facility': 'Pathologisches Institut Recklinghausen', 'geoPoint': {'lat': 51.61379, 'lon': 7.19738}}, {'zip': '72764', 'city': 'Reutlingen', 'country': 'Germany', 'facility': 'Klinikum am Steinenberg / Ermstalklinik', 'geoPoint': {'lat': 48.49144, 'lon': 9.20427}}, {'zip': '27356', 'city': 'Rotenburg (Wümme)', 'country': 'Germany', 'facility': 'Diakoniekrankenhaus Institut f.Pathologie', 'geoPoint': {'lat': 53.11032, 'lon': 9.4036}}, {'zip': '97422', 'city': 'Schweinfurt', 'country': 'Germany', 'facility': 'Leopoldina Krankenhaus der Stadt Schweinfurt GmbH; Pathologie', 'geoPoint': {'lat': 50.04937, 'lon': 10.22175}}, {'zip': '19049', 'city': 'Schwerin', 'country': 'Germany', 'facility': 'HELIOS Klinikum Schwerin; Frauenklinik', 'geoPoint': {'lat': 53.62937, 'lon': 11.41316}}, {'zip': '39576', 'city': 'Stendal', 'country': 'Germany', 'facility': 'Gemeinschaftspraxis PD Dr.med. Meinald Schultz und Dr.med. Petra Lüders', 'geoPoint': {'lat': 52.6069, 'lon': 11.85867}}, {'zip': '70376', 'city': 'Stuttgart', 'country': 'Germany', 'facility': 'Robert-Bosch-Krankenhaus; Pathologisches Institut', 'geoPoint': {'lat': 48.78232, 'lon': 9.17702}}, {'zip': '92637', 'city': 'Weiden', 'country': 'Germany', 'facility': 'Gemeinschaftspraxis für Pathologie Weiden; am Klinikum Weiden; Giedl, Stelter und Meier', 'geoPoint': {'lat': 49.67682, 'lon': 12.15613}}], 'overallOfficials': [{'name': 'Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Hoffmann-La Roche'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hoffmann-La Roche', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}