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NCT Number: NCT05934032

National Network Genomic Medicine Lung Cancer, Germany

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

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Key information

Conditions

Carcinoma, Non-Small-Cell Lung Bronchial Neoplasms Carcinoma Carcinoma, Bronchogenic Disease Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Pathologic Processes Pathological Conditions, Signs and Symptoms Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital Cologne

Cologne, Germany

Location status: Recruiting

Location contact

Anna Rasokat

CONTACT

[email protected]

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

observational, non-interventional

Other

observational, non-interventional

Primary outcomes

  1. molecular testing

    Time frame: 1 year

    descriptive data on results, frequency and methods of molecular testing

  2. treatment patterns

    Time frame: from first diagnosis to death or loss to follow-up, whichever came first, assessed up to 100 months

    descriptive data on systemic treatments (including combination and sequence of treatments)

  3. overall survival

    Time frame: assessed up to 100 months

    overall survival (in months)

  4. 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

    time to next treatment (in months)

  5. 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

    progression free survival (in months)

Study contacts

Contact information is provided by the study sponsor or research team.

Anna Rasokat

CONTACT

[email protected]

004922147896992

nNGM Geschäftsstelle

CONTACT

[email protected]

004922147896991

Sponsors and collaborators

Lead sponsor

Prof. Dr. Juergen Wolf

Other

Collaborators

  • Charite University, Berlin, Germany
  • Goethe University
  • Heinrich-Heine University, Duesseldorf
  • Helios Klinikum Emil von Behring
  • Johannes Gutenberg University Mainz
  • Klinikum Hanover-Siloah Hospital
  • Pius-Hospital Oldenburg
  • Robert Bosch Gesellschaft für Medizinische Forschung mbH (RBMF)
  • University Hospital Carl Gustav Carus
  • University Hospital Erlangen
  • University Hospital Freiburg
  • University Hospital Giessen and Marburg
  • University Hospital Halle (Saale)
  • University Hospital Heidelberg
  • University Hospital Munich
  • University Hospital Regensburg
  • University Hospital Schleswig-Holstein
  • University Hospital Tuebingen
  • University Hospital Ulm
  • University Hospital of Cologne
  • University Hospital rechts der Isar Munich (TUM)
  • University Hospital, Bonn
  • University Hospital, Essen
  • Universitätsklinikum Hamburg-Eppendorf
  • Vivantes Hospital Berlin Neukölln
  • Wuerzburg University Hospital

Registry information

Official study 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

Acronym: nNGM

Important dates

Study start
2018
Primary completion
2030
Study completion
2030
First posted
Jul 6, 2023
Registry last updated
Jul 6, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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