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Trial Title: National Network Genomic Medicine Lung Cancer, Germany

NCT ID: NCT05934032

Condition: Carcinoma, Non-Small-Cell Lung

Conditions: Official terms:
Carcinoma
Carcinoma, Non-Small-Cell Lung

Conditions: Keywords:
carcinoma, non-small-cell lung* / diagnosis
carcinoma, non-small-cell lung* / genetics
precision medicine
lung neoplasms
neoplasms by site
registry
pathology, molecular

Study type: Observational [Patient Registry]

Overall status: Recruiting

Study design:

Time perspective: Prospective

Intervention:

Intervention type: Other
Intervention name: observational, non-interventional
Description: observational, non-interventional

Summary: 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.

Criteria for eligibility:

Study pop:
Participants with histologically confirmed NSCLC are enrolled by 23 certified cancer centres and more than 400 network partners (hospitals and oncological practices) across Germany.

Sampling method: Non-Probability Sample
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

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: University Hospital Cologne

Address:
City: Cologne
Country: Germany

Status: Recruiting

Contact:
Last name: Anna Rasokat
Email: anna.rasokat@uk-koeln.de

Start date: April 1, 2018

Completion date: December 31, 2030

Lead sponsor:
Agency: Prof. Dr. Juergen Wolf
Agency class: Other

Collaborator:
Agency: Charite University, Berlin, Germany
Agency class: Other

Collaborator:
Agency: Helios Klinikum Emil von Behring
Agency class: Other

Collaborator:
Agency: Vivantes Hospital Berlin Neukölln
Agency class: Other

Collaborator:
Agency: University Hospital Carl Gustav Carus
Agency class: Other

Collaborator:
Agency: Heinrich-Heine University, Duesseldorf
Agency class: Other

Collaborator:
Agency: University Hospital Erlangen
Agency class: Other

Collaborator:
Agency: University Hospital, Essen
Agency class: Other

Collaborator:
Agency: Goethe University
Agency class: Other

Collaborator:
Agency: University Hospital Freiburg
Agency class: Other

Collaborator:
Agency: University Hospital Giessen and Marburg
Agency class: Other

Collaborator:
Agency: University Hospital Halle (Saale)
Agency class: Other

Collaborator:
Agency: Universitätsklinikum Hamburg-Eppendorf
Agency class: Other

Collaborator:
Agency: University Hospital Heidelberg
Agency class: Other

Collaborator:
Agency: Klinikum Hanover-Siloah Hospital
Agency class: Other

Collaborator:
Agency: University Hospital, Bonn
Agency class: Other

Collaborator:
Agency: University Hospital Schleswig-Holstein
Agency class: Other

Collaborator:
Agency: Johannes Gutenberg University Mainz
Agency class: Other

Collaborator:
Agency: University Hospital Munich (LMU)
Agency class: Other

Collaborator:
Agency: University Hospital rechts der Isar Munich (TUM)
Agency class: Other

Collaborator:
Agency: Pius-Hospital Oldenburg
Agency class: Other

Collaborator:
Agency: University Hospital Regensburg
Agency class: Other

Collaborator:
Agency: University Hospital Tuebingen
Agency class: Other

Collaborator:
Agency: Robert Bosch Hospital Stuttgart
Agency class: Other

Collaborator:
Agency: University Hospital Ulm
Agency class: Other

Collaborator:
Agency: Wuerzburg University Hospital
Agency class: Other

Collaborator:
Agency: University Hospital of Cologne
Agency class: Other

Source: University of Cologne

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05934032
https://nngm.de

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