Ignite Creation Date:
2025-12-24 @ 9:32 PM
Ignite Modification Date:
2025-12-30 @ 10:19 PM
Study NCT ID:
NCT05934032
Status:
RECRUITING
Last Update Posted:
2023-07-06
First Post:
2023-06-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
National Network Genomic Medicine Lung Cancer, Germany
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002289', 'term': 'Carcinoma, Non-Small-Cell Lung'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D004194', 'term': 'Disease'}, {'id': 'D008175', 'term': 'Lung Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}], 'ancestors': [{'id': 'D002283', 'term': 'Carcinoma, Bronchogenic'}, {'id': 'D001984', 'term': 'Bronchial Neoplasms'}, {'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30000}, 'targetDuration': '10 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-07', 'completionDateStruct': {'date': '2030-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-07-03', 'studyFirstSubmitDate': '2023-06-16', 'studyFirstSubmitQcDate': '2023-07-03', 'lastUpdatePostDateStruct': {'date': '2023-07-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-07-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2030-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'molecular testing', 'timeFrame': '1 year', 'description': 'descriptive data on results, frequency and methods of molecular testing'}, {'measure': 'treatment patterns', 'timeFrame': 'from first diagnosis to death or loss to follow-up, whichever came first, assessed up to 100 months', 'description': 'descriptive data on systemic treatments (including combination and sequence of treatments)'}, {'measure': 'overall survival', 'timeFrame': 'assessed up to 100 months', 'description': 'overall survival (in months)'}, {'measure': 'time to next treatment', 'timeFrame': 'from start of treatment to the start of the next therapy, death or loss to follow-up, whichever came first, assessed up to 100 months', 'description': 'time to next treatment (in months)'}, {'measure': 'progression free survival', 'timeFrame': 'from start of treatment to tumour progression, death or loss to follow-up, whichever came first, assessed up to 100 months', 'description': 'progression free survival (in months)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['carcinoma, non-small-cell lung* / diagnosis', 'carcinoma, non-small-cell lung* / genetics', 'precision medicine', 'lung neoplasms', 'neoplasms by site', 'registry', 'pathology, molecular'], 'conditions': ['Carcinoma, Non-Small-Cell Lung']}, 'referencesModule': {'references': [{'pmid': '35263633', 'type': 'BACKGROUND', 'citation': 'Janning M, Suptitz J, Albers-Leischner C, Delpy P, Tufman A, Velthaus-Rusik JL, Reck M, Jung A, Kauffmann-Guerrero D, Bonzheim I, Brandlein S, Hummel HD, Wiesweg M, Schildhaus HU, Stratmann JA, Sebastian M, Alt J, Buth J, Esposito I, Berger J, Togel L, Saalfeld FC, Wermke M, Merkelbach-Bruse S, Hillmer AM, Klauschen F, Bokemeyer C, Buettner R, Wolf J, Loges S; National Network Genomic Medicine Lung Cancer (nNGM). Treatment outcome of atypical EGFR mutations in the German National Network Genomic Medicine Lung Cancer (nNGM). Ann Oncol. 2022 Jun;33(6):602-615. doi: 10.1016/j.annonc.2022.02.225. Epub 2022 Mar 6.'}, {'pmid': '34601169', 'type': 'BACKGROUND', 'citation': 'Saleh MM, Scheffler M, Merkelbach-Bruse S, Scheel AH, Ulmer B, Wolf J, Buettner R. Comprehensive Analysis of TP53 and KEAP1 Mutations and Their Impact on Survival in Localized- and Advanced-Stage NSCLC. J Thorac Oncol. 2022 Jan;17(1):76-88. doi: 10.1016/j.jtho.2021.08.764. Epub 2021 Sep 30.'}, {'pmid': '34245914', 'type': 'BACKGROUND', 'citation': 'Saalfeld FC, Wenzel C, Christopoulos P, Merkelbach-Bruse S, Reissig TM, Lassmann S, Thiel S, Stratmann JA, Marienfeld R, Berger J, Desuki A, Velthaus JL, Kauffmann-Guerrero D, Stenzinger A, Michels S, Herold T, Kramer M, Herold S, Tufman A, Loges S, Alt J, Joosten M, Schmidtke-Schrezenmeier G, Sebastian M, Stephan-Falkenau S, Waller CF, Wiesweg M, Wolf J, Thomas M, Aust DE, Wermke M; National Network Genomic Medicine Lung Cancer (nNGM). Efficacy of Immune Checkpoint Inhibitors Alone or in Combination With Chemotherapy in NSCLC Harboring ERBB2 Mutations. J Thorac Oncol. 2021 Nov;16(11):1952-1958. doi: 10.1016/j.jtho.2021.06.025. Epub 2021 Jul 8.'}], 'seeAlsoLinks': [{'url': 'https://nngm.de', 'label': 'Website of the national Network Genomic Medicine Lung Cancer, Germany'}]}, 'descriptionModule': {'briefSummary': 'Registry of the national Network Genomic Medicine Lung Cancer (nNGM), linking data on molecular diagnostics, clinical characteristics, treatment patterns and outcomes of subjects with non-small cell lung cancer (NSCLC) from 23 specialized cancer centres and more than 400 general hospitals and oncological practices in Germany', 'detailedDescription': 'Within the national Network Genomic Medicine Lung Cancer (nNGM), comprehensive molecular diagnostics and treatment recommendations are provided by 23 certified cancer centres according to standardized procedures for patients with non-resectable NSCLC. More than 400 network partners across Germany (including hospitals and oncological practices) report data on subsequent treatment and outcomes to the nNGM registry. Clinical outcomes are continuously evaluated through analysis of data collected in a decentralized registry. The nNGM registry records the patient journey and course of the disease from first histologically confirmed diagnosis to death or loss to follow-up and comprises detailed data on demographic and clinical characteristics, molecular diagnostics (including comprehensive biomarker testing results), treatments (targeted therapy, immunotherapy, chemotherapy, radiotherapy, best supportive care) and outcomes (overall survival, response, disease progression, time to next treatment). Patients have been actively involved throughout all stages of the design and running of the network and its registry.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Participants with histologically confirmed NSCLC are enrolled by 23 certified cancer centres and more than 400 network partners (hospitals and oncological practices) across Germany.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥ 18 years\n* Histologically confirmed, locally advanced or metastatic NSCLC (Union for International Cancer Control \\[UICC\\] stage IIIb/IV; non-resectable NSCLC)\n* From 07/2023: histologically confirmed NSCLC stage Ib, II, III (UICC)\n\nExclusion Criteria:\n\n* Missing written informed consent'}, 'identificationModule': {'nctId': 'NCT05934032', 'acronym': 'nNGM', 'briefTitle': 'National Network Genomic Medicine Lung Cancer, Germany', 'organization': {'class': 'OTHER', 'fullName': 'University of Cologne'}, 'officialTitle': 'Registry of the National Network Genomic Medicine Lung Cancer (nNGM), Linking Data on Molecular Diagnostics, Clinical Characteristics, Treatment Patterns and Outcomes of Subjects With Non-Small Cell Lung Cancer in Germany', 'orgStudyIdInfo': {'id': 'NNGM0418'}}, 'armsInterventionsModule': {'interventions': [{'name': 'observational, non-interventional', 'type': 'OTHER', 'description': 'observational, non-interventional'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cologne', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Anna Rasokat', 'role': 'CONTACT', 'email': 'anna.rasokat@uk-koeln.de'}], 'facility': 'University Hospital Cologne', 'geoPoint': {'lat': 50.93333, 'lon': 6.95}}], 'centralContacts': [{'name': 'Anna Rasokat', 'role': 'CONTACT', 'email': 'anna.rasokat@uk-koeln.de', 'phone': '004922147896992'}, {'name': 'nNGM Geschäftsstelle', 'role': 'CONTACT', 'email': 'NNGM-Geschaeftsstelle@uk-koeln.de', 'phone': '004922147896991'}], 'overallOfficials': [{'name': 'Juergen Wolf, Prof. Dr.', 'role': 'STUDY_CHAIR', 'affiliation': 'University of Cologne'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Prof. Dr. Juergen Wolf', 'class': 'OTHER'}, 'collaborators': [{'name': 'Charite University, Berlin, Germany', 'class': 'OTHER'}, {'name': 'Helios Klinikum Emil von Behring', 'class': 'UNKNOWN'}, {'name': 'Vivantes Hospital Berlin Neukölln', 'class': 'UNKNOWN'}, {'name': 'University Hospital Carl Gustav Carus', 'class': 'OTHER'}, {'name': 'Heinrich-Heine University, Duesseldorf', 'class': 'OTHER'}, {'name': 'University Hospital Erlangen', 'class': 'OTHER'}, {'name': 'University Hospital, Essen', 'class': 'OTHER'}, {'name': 'Goethe University', 'class': 'OTHER'}, {'name': 'University Hospital Freiburg', 'class': 'OTHER'}, {'name': 'University Hospital Giessen and Marburg', 'class': 'UNKNOWN'}, {'name': 'University Hospital Halle (Saale)', 'class': 'UNKNOWN'}, {'name': 'Universitätsklinikum Hamburg-Eppendorf', 'class': 'OTHER'}, {'name': 'University Hospital Heidelberg', 'class': 'OTHER'}, {'name': 'Klinikum Hanover-Siloah Hospital', 'class': 'OTHER'}, {'name': 'University Hospital, Bonn', 'class': 'OTHER'}, {'name': 'University Hospital Schleswig-Holstein', 'class': 'OTHER'}, {'name': 'Johannes Gutenberg University Mainz', 'class': 'OTHER'}, {'name': 'University Hospital Munich (LMU)', 'class': 'UNKNOWN'}, {'name': 'University Hospital rechts der Isar Munich (TUM)', 'class': 'UNKNOWN'}, {'name': 'Pius-Hospital Oldenburg', 'class': 'OTHER'}, {'name': 'University Hospital Regensburg', 'class': 'OTHER'}, {'name': 'University Hospital Tuebingen', 'class': 'OTHER'}, {'name': 'Robert Bosch Gesellschaft für Medizinische Forschung mbH (RBMF)', 'class': 'OTHER'}, {'name': 'University Hospital Ulm', 'class': 'OTHER'}, {'name': 'Wuerzburg University Hospital', 'class': 'OTHER'}, {'name': 'University Hospital of Cologne', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Professor Dr. med., Spokesperson of the National Network Genomic Medicine Lung Cancer', 'investigatorFullName': 'Prof. Dr. Juergen Wolf', 'investigatorAffiliation': 'University of Cologne'}}}}