nNGM: National Network Genomic Medicine Lung Cancer, Germany

Sponsor

Prof. Dr. Juergen Wolf (Other)

Overall Status

Recruiting

CT.gov ID

NCT05934032

Collaborator

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

30,000

Enrollment

Location

153

Anticipated Duration (Months)

196.1

Patients Per Site Per Month

Study Details

Study Description

Brief 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

Condition or Disease	Intervention/Treatment	Phase
Carcinoma, Non-Small-Cell Lung	Other: observational, non-interventional

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.

Study Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

30000 participants

Observational Model:

Cohort

Time Perspective:

Prospective

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

Actual Study Start Date :

Apr 1, 2018

Anticipated Primary Completion Date :

Dec 31, 2030

Anticipated Study Completion Date :

Dec 31, 2030

Outcome Measures

Primary Outcome Measures

molecular testing [1 year]
descriptive data on results, frequency and methods of molecular testing
treatment patterns [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)
overall survival [assessed up to 100 months]
overall survival (in months)
time to next treatment [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)
progression free survival [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)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Hospital Cologne	Cologne		Germany

Investigators

Study Chair: Juergen Wolf, Prof. Dr., University of Cologne

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Website of the national Network Genomic Medicine Lung Cancer, Germany

Publications

Responsible Party:

Prof. Dr. Juergen Wolf, Professor Dr. med., Spokesperson of the National Network Genomic Medicine Lung Cancer, University of Cologne

ClinicalTrials.gov Identifier:

NCT05934032

Other Study ID Numbers:

NNGM0418

First Posted:

Jul 6, 2023

Last Update Posted:

Jul 6, 2023

Last Verified:

Jul 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Prof. Dr. Juergen Wolf, Professor Dr. med., Spokesperson of the National Network Genomic Medicine Lung Cancer, University of Cologne

carcinoma, non-small-cell lung* / diagnosis

carcinoma, non-small-cell lung* / genetics

Additional relevant MeSH terms:

Carcinoma

Carcinoma, Non-Small-Cell Lung