NCT05934032

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30,000

participants targeted

Target at P75+ for all trials

Timeline
56mo left

Started Apr 2018

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress64%
Apr 2018Dec 2030

Study Start

First participant enrolled

April 1, 2018

Completed
5.2 years until next milestone

First Submitted

Initial submission to the registry

June 16, 2023

Completed
20 days until next milestone

First Posted

Study publicly available on registry

July 6, 2023

Completed
7.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2030

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2030

Last Updated

July 6, 2023

Status Verified

July 1, 2023

Enrollment Period

12.8 years

First QC Date

June 16, 2023

Last Update Submit

July 3, 2023

Conditions

Carcinoma, Non-Small-Cell Lung

Keywords

carcinoma, non-small-cell lung* / diagnosiscarcinoma, non-small-cell lung* / geneticsprecision medicinelung neoplasmsneoplasms by siteregistrypathology, molecular

Outcome Measures

Primary Outcomes (5)

  • molecular testing

    descriptive data on results, frequency and methods of molecular testing

    1 year

  • treatment patterns

    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

    overall survival (in months)

    assessed up to 100 months

  • time to next treatment

    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

    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

Interventions

observational, non-interventionalOTHER

observational, non-interventional

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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)

You may not qualify if:

  • Missing written informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Cologne

Cologne, Germany

RECRUITING

Related Publications (3)

  • 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.

    PMID: 35263633BACKGROUND

  • 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.

    PMID: 34601169BACKGROUND

  • 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.

    PMID: 34245914BACKGROUND

Related Links

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell LungCarcinomaDiseaseLung NeoplasmsNeoplasms by Site

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasmsLung DiseasesRespiratory Tract DiseasesNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypePathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Juergen Wolf, Prof. Dr.

    University of Cologne

    STUDY CHAIR

Central Study Contacts

Anna Rasokat

CONTACT

004922147896992anna.rasokat@uk-koeln.de

nNGM Geschäftsstelle

CONTACT

004922147896991NNGM-Geschaeftsstelle@uk-koeln.de

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
10 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor Dr. med., Spokesperson of the National Network Genomic Medicine Lung Cancer

Study Record Dates

First Submitted

June 16, 2023

First Posted

July 6, 2023

Study Start

April 1, 2018

Primary Completion (Estimated)

December 31, 2030

Study Completion (Estimated)

December 31, 2030

Last Updated

July 6, 2023

Record last verified: 2023-07

Locations

DE(1)