National Network Genomic Medicine Lung Cancer, Germany

NCT ID: NCT05934032

Last Updated: 2023-07-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

30000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-04-01

Study Completion Date

2030-12-31

Brief Summary

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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

Detailed Description

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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.

Conditions

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Carcinoma, Non-Small-Cell Lung

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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observational, non-interventional

observational, non-interventional

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Age ≥ 18 years
* Histologically confirmed, locally advanced or metastatic NSCLC (Union for International Cancer Control \[UICC\] stage IIIb/IV; non-resectable NSCLC)
* From 07/2023: histologically confirmed NSCLC stage Ib, II, III (UICC)

Exclusion Criteria

* Missing written informed consent
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Charite University, Berlin, Germany

OTHER

Sponsor Role collaborator

Helios Klinikum Emil von Behring

UNKNOWN

Sponsor Role collaborator

Vivantes Hospital Berlin Neukölln

UNKNOWN

Sponsor Role collaborator

University Hospital Carl Gustav Carus

OTHER

Sponsor Role collaborator

Heinrich-Heine University, Duesseldorf

OTHER

Sponsor Role collaborator

University Hospital Erlangen

OTHER

Sponsor Role collaborator

University Hospital, Essen

OTHER

Sponsor Role collaborator

Goethe University

OTHER

Sponsor Role collaborator

University Hospital Freiburg

OTHER

Sponsor Role collaborator

University Hospital Giessen and Marburg

UNKNOWN

Sponsor Role collaborator

University Hospital Halle (Saale)

UNKNOWN

Sponsor Role collaborator

Universitätsklinikum Hamburg-Eppendorf

OTHER

Sponsor Role collaborator

University Hospital Heidelberg

OTHER

Sponsor Role collaborator

Klinikum Hanover-Siloah Hospital

OTHER

Sponsor Role collaborator

University Hospital, Bonn

OTHER

Sponsor Role collaborator

University Hospital Schleswig-Holstein

OTHER

Sponsor Role collaborator

Johannes Gutenberg University Mainz

OTHER

Sponsor Role collaborator

University Hospital Munich (LMU)

UNKNOWN

Sponsor Role collaborator

University Hospital rechts der Isar Munich (TUM)

UNKNOWN

Sponsor Role collaborator

Pius-Hospital Oldenburg

OTHER

Sponsor Role collaborator

University Hospital Regensburg

OTHER

Sponsor Role collaborator

University Hospital Tuebingen

OTHER

Sponsor Role collaborator

Robert Bosch Gesellschaft für Medizinische Forschung mbH (RBMF)

OTHER

Sponsor Role collaborator

University Hospital Ulm

OTHER

Sponsor Role collaborator

Wuerzburg University Hospital

OTHER

Sponsor Role collaborator

University Hospital of Cologne

OTHER

Sponsor Role collaborator

Prof. Dr. Juergen Wolf

OTHER

Sponsor Role lead

Responsible Party

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Prof. Dr. Juergen Wolf

Professor Dr. med., Spokesperson of the National Network Genomic Medicine Lung Cancer

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Juergen Wolf, Prof. Dr.

Role: STUDY_CHAIR

University of Cologne

Locations

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University Hospital Cologne

Cologne, , Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Anna Rasokat

Role: CONTACT

004922147896992

nNGM Geschäftsstelle

Role: CONTACT

004922147896991

Facility Contacts

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Anna Rasokat

Role: primary

References

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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.

Reference Type BACKGROUND
PMID: 35263633 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 34601169 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 34245914 (View on PubMed)

Related Links

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https://nngm.de

Website of the national Network Genomic Medicine Lung Cancer, Germany

Other Identifiers

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NNGM0418

Identifier Type: -

Identifier Source: org_study_id

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