National Network Genomic Medicine Lung Cancer, Germany

Studien-Informationen Einschlusskriterien Studien-Rationale Geprüfte Regime

Rekrutierend

NCT-Nummer:
NCT05934032

Studienbeginn:
April 2018

Letztes Update:
06.07.2023

Wirkstoff:
-

Indikation (Clinical Trials):
Carcinoma, Carcinoma, Non-Small-Cell Lung

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
-

Sponsor:
Prof. Dr. Juergen Wolf

Collaborator:
Charite University, Berlin, Germany, Helios Klinikum Emil von Behring, Vivantes Hospital Berlin Neukölln, University Hospital Carl Gustav Carus, Heinrich-Heine University, Duesseldorf, University Hospital Erlangen, University Hospital, Essen, Goethe University, U

Studienleiter

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

Kontakt

Anna Rasokat
Kontakt:
Phone: 004922147896992
E-Mail: anna.rasokat@uk-koeln.de» Kontaktdaten anzeigen

nNGM Geschäftsstelle
Kontakt:
Phone: 004922147896991
E-Mail: NNGM-Geschaeftsstelle@uk-koeln.de» Kontaktdaten anzeigen

Studienlocations
(1 von 1)

University Hospital Cologne
Cologne
(Nordrhein-Westfalen)
GermanyRekrutierend» Google-Maps
Ansprechpartner:
Anna Rasokat
E-Mail: anna.rasokat@uk-koeln.de» Ansprechpartner anzeigen

Studien-Informationen

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.

Ein-/Ausschlusskriterien

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

Studien-Rationale

Primary outcome:

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)

Geprüfte Regime

observational, non-interventional:
observational, non-interventional

Quelle: ClinicalTrials.gov

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