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Recruiting NCT05934032

National Network Genomic Medicine Lung Cancer, Germany

— Observational Carcinoma, Non-Small-Cell Lung

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: observational, non-interventional.
Who it may be relevant to
Registry conditions: Carcinoma, Non-Small-Cell Lung. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Germany
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

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.

Interventions

  • Other observational, non-interventional
    observational, non-interventional

Primary outcome measures

  • molecular testing [Time frame: 1 year]
  • treatment patterns [Time frame: from first diagnosis to death or loss to follow-up, whichever came first, assessed up to 100 months]
  • overall survival [Time frame: assessed up to 100 months]
  • time to next treatment [Time frame: 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]
  • progression free survival [Time frame: from start of treatment to tumour progression, death or loss to follow-up, whichever came first, assessed up to 100 months]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Germany · 1 center
  • University Hospital Cologne — Cologne

Publications

  • 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 Lun PMID 35263633
  • 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 34601169
  • 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 Netw PMID 34245914
  • Bischoff P, Reck M, Overbeck T, Christopoulos P, Rittmeyer A, Luders H, Kollmeier J, Kulhavy J, Kemper M, Reinmuth N, Roper J, Janning M, Sommer L, Aguinarte L, Koch M, Wiesweg M, Wesseler C, Waller CF, Kauffmann-Guerrero D, Stenzinger A, Stephan-Falkenau S, Trautmann M, Lassmann S, Tiemann M, Klauschen F, Sebastian M, Griesinger F, Wolf J, Loges S, Frost N; National Network Genomic Medicine Lung PMID 38096950

Identifiers

NCT: NCT05934032 · NNGM0418

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗