National Network Genomic Medicine Lung Cancer, Germany (nNGM)
July 3, 2023 updated by: Prof. Dr. Juergen Wolf
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
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
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
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 Type
Observational
Enrollment (Estimated)
30000
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Anna Rasokat
- Phone Number: 004922147896992
- Email: anna.rasokat@uk-koeln.de
Study Contact Backup
- Name: nNGM Geschäftsstelle
- Phone Number: 004922147896991
- Email: NNGM-Geschaeftsstelle@uk-koeln.de
Study Locations
-
-
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Cologne, Germany
- Recruiting
- University Hospital Cologne
-
Contact:
- Anna Rasokat
- Email: anna.rasokat@uk-koeln.de
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
Participants with histologically confirmed NSCLC are enrolled by 23 certified cancer centres and more than 400 network partners (hospitals and oncological practices) across Germany.
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
molecular testing
Time Frame: 1 year
|
descriptive data on results, frequency and methods of molecular testing
|
1 year
|
|
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)
|
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
|
overall survival (in months)
|
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
|
time to next treatment (in months)
|
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
|
progression free survival (in months)
|
from start of treatment to tumour progression, death or loss to follow-up, whichever came first, assessed up to 100 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Study Chair: Juergen Wolf, Prof. Dr., University of Cologne
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General 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 Lung Cancer (nNGM). Treatment outcome of atypical EGFR mutations in the German National Network Genomic Medicine Lung Cancer (nNGM). Ann Oncol. 2022 Jun;33(6):602-615. doi: 10.1016/j.annonc.2022.02.225. Epub 2022 Mar 6.
- 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.
- 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 Network Genomic Medicine Lung Cancer (nNGM). Efficacy of Immune Checkpoint Inhibitors Alone or in Combination With Chemotherapy in NSCLC Harboring ERBB2 Mutations. J Thorac Oncol. 2021 Nov;16(11):1952-1958. doi: 10.1016/j.jtho.2021.06.025. Epub 2021 Jul 8.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 1, 2018
Primary Completion (Estimated)
December 31, 2030
Study Completion (Estimated)
December 31, 2030
Study Registration Dates
First Submitted
June 16, 2023
First Submitted That Met QC Criteria
July 3, 2023
First Posted (Actual)
July 6, 2023
Study Record Updates
Last Update Posted (Actual)
July 6, 2023
Last Update Submitted That Met QC Criteria
July 3, 2023
Last Verified
July 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- NNGM0418
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.