Improvement of Personalized Lung Cancer Care Through Digital Connection and Patient Participation (DigiNet)
DigiNet
Improvement of Personalized Cancer Care for Patients With Advanced Non-Small Cell Lung Cancer (NSCLC) Through Digital Connection of Specialized Cancer Centers, Community Hospitals, Private Practices and Patients (DigiNet)
1 other identifier
interventional
850
1 country
41
Brief Summary
The aim of the DigiNet project is to improve the treatment of patients with advanced non-small cell lung cancer (NSCLC) in Germany. The project promotes the transfer of the latest scientific knowledge into standard care. The DigiNet project is based on the established precision medicine program, the National Network Genomic Medicine Lung Cancer (nNGM) in Germany, whereby every patient receives molecular diagnostics and personalized therapy information after the initial diagnosis. Within the framework of the DigiNet project, specialized academic centers will be digitally connected with practitioners via a shared project database. Furthermore, a committee of experts will monitor the course of treatment and will advise the practitioners in case of critical conditions. Additionally, patient-reported outcomes will be incorporated into the treatment.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jun 2022
Typical duration for not_applicable
41 active sites
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 Start
First participant enrolled
June 1, 2022
CompletedFirst Submitted
Initial submission to the registry
December 12, 2022
CompletedFirst Posted
Study publicly available on registry
April 18, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
March 31, 2025
CompletedJune 4, 2024
June 1, 2024
2.8 years
December 12, 2022
June 3, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Overall Survival (OS)
Overall Survival (OS) will be assessed in months.
up to 34 months
Secondary Outcomes (16)
Progression-Free Survival (PFS)
up to 34 months
Time on First Treatment (ToT)
up to 34 months
Hospitalization rate
up to 34 months
Quality of Life (EORTC QLQ-C30)
up to 34 months
Quality of Life (EORTC QLQ-LC29)
up to 34 months
- +11 more secondary outcomes
Study Arms (2)
DigiNet group
EXPERIMENTALThe intervention group will receive the DigiNet intervention.
Comparison group
NO INTERVENTIONThe comparison group will receive usual care.
Interventions
Patients with initial diagnosis of NSCLC stage IV in the model region receiving the following interventions: * broad NGS-based molecular diagnostics and, based thereupon, personalized treatment information within the national Network Genomic Medicine (nNGM) lung cancer * regular clinical follow-up visits and data documentation in the shared central digital database by participating physicians * monthly assessment of patient-reported outcomes (PRO) on quality of life, anxiety, and depression * incorporation of PROs into treatment by physicians * treatment monitoring and counseling in the case of critical conditions by expert committee
Eligibility Criteria
You may qualify if:
- Patients diagnosed with advanced NSCLC, stage IV
- Age \> 18 years
You may not qualify if:
- Missing informed consent
- Illnesses and behaviors that impair compliance (e.g., dementia, addictive disorders)
- Severely impaired general physical condition that no longer permits therapy for lung cancer
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Colognelead
- Gemeinsamer Bundesausschuss (G-BA)collaborator
- AOK Rheinland/Hamburgcollaborator
- AOK Nordwestcollaborator
- BARMERcollaborator
- University Hospital, Essencollaborator
- Charite University, Berlin, Germanycollaborator
- Berlin Institute of Healthcollaborator
- Helios Klinikum Emil von Behringcollaborator
- University Hospital Carl Gustav Caruscollaborator
- Deutsche Krebsgesellschaft e.V.collaborator
- Berufsverband der Niedergelassenen Hämatologen und Onkologen in Deutschland e.V.collaborator
- AOK Bundesverbandcollaborator
- FOM Hochschule für Oekonomie und Managementcollaborator
- University Medicine Greifswaldcollaborator
- Technische Universität Dresdencollaborator
Study Sites (41)
Universitätsklinikum Würzburg
Würzburg, Bavaria, 97080, Germany
Hämatologisch-Onkologische Schwerpunktpraxis
Bad Liebenwerda, Brandenburg, 04924, Germany
Universitätsklinikum Aachen
Aachen, North Rhine-Westphalia, 52074, Germany
Johanniter-Krankenhaus Bonn
Bonn, North Rhine-Westphalia, 53113, Germany
Onkozentrum Bonn
Bonn, North Rhine-Westphalia, 53123, Germany
Universitätsklinikum Bonn (UKB)
Bonn, North Rhine-Westphalia, 53127, Germany
Zentrum für ambulante Hämatologie und Onkologie Rhein-Sieg (ZAHO)
Brühl, North Rhine-Westphalia, 50321, Germany
MV-Zentrum für Hämatologie und Onkologie
Cologne, North Rhine-Westphalia, 50677, Germany
Universitätsklinikum Köln
Cologne, North Rhine-Westphalia, 50937, Germany
MVZ West GmbH Standort Köln-Kalk
Cologne, North Rhine-Westphalia, 51103, Germany
Praxis Internistischer Onkologie und Hämatologie (pioh)
Cologne, North Rhine-Westphalia, Germany
Gemeinschaftspraxis für Hämatologie & Onkologie
Dortmund, North Rhine-Westphalia, 44263, Germany
Universitätsklinikum Essen
Essen, North Rhine-Westphalia, 45147, Germany
Praxis für Hämatologie und Internistische Onkologie
Hamm, North Rhine-Westphalia, 59065, Germany
Klinikum Leverkusen
Leverkusen, North Rhine-Westphalia, 51375, Germany
Kliniken Maria Hilf GmbH
Mönchengladbach, North Rhine-Westphalia, 41063, Germany
MVZ für Hämatologie und Onkologie
Mülheim, North Rhine-Westphalia, 45468, Germany
Praxis und Tagesklinik für Internistische Onkologie und Hämatologie
Recklinghausen, North Rhine-Westphalia, 45659, Germany
Krankenhaus Bethanien Solingen
Solingen, North Rhine-Westphalia, 42699, Germany
Onkologie Rheinsieg
Troisdorf/Bonn-Beuel/Bad Honnef, North Rhine-Westphalia, 53840, Germany
MVZ Medizinisches Versorgungszentrum am Marien-Hospital Wesel
Wesel, North Rhine-Westphalia, 46483, Germany
Medizinisches Versorgungzentrum am Evangelischen Krankenhaus Wesel GmbH
Wesel, North Rhine-Westphalia, 46485, Germany
Onkologie Erzgebirge
Aue-Bad Schlema, Saxony, 08301, Germany
Hämatologisch Onkologisches Centrum Ostsachsen ONCOS GmbH
Bautzen, Saxony, 02625, Germany
Fachkrankenhaus Coswig
Coswig, Saxony, 01640, Germany
Gemeinschaftspraxis Dr. med. Johannes Mohm Dr. med. Gabriele Prange-Krex
Dresden, Saxony, 01307, Germany
Gemeinschaftspraxis Hämatologie - Onkologie
Dresden, Saxony, 01307, Germany
Universitätsklinikum Carl Gustav Carus Dresden
Dresden, Saxony, 01307, Germany
Onkozentrum Dresden/Freiberg/Meißen
Dresden/Freiberg/Meißen, Saxony, Germany
Ambulante Onkologie Ostsachsen
Zittau, Saxony, 02763, Germany
Helios Klinikum Erfurt
Erfurt, Thuringia, 99089, Germany
Charité Universitätsmedizin Berlin
Berlin, 10117, Germany
Onkologische Schwerpunktpraxis Tiergarten
Berlin, 10559, Germany
Onkologische Schwerpunktpraxis Kurfürstendamm
Berlin, 10707, Germany
Praxis am Volkspark
Berlin, 10715, Germany
Vivantes Klinikum Neukölln
Berlin, 12351, Germany
Evangelische Lungenklinik Berlin
Berlin, 13125, Germany
DRK Kliniken Berlin Mitte
Berlin, 13359, Germany
Gemeinschaftskrankenhaus Havelhöhe
Berlin, 14089, Germany
Helios Klinikum Emil von Behring
Berlin, 14165, Germany
Onkologischer Schwerpunkt am Oskar-Helene-Heim
Berlin, 14195, Germany
Related Publications (1)
Kastner A, Kron A, Eilers L, Spier A, Mildenberger V, Simic D, Stock S, Kron F, Scheffler M, Schillinger G, van den Berg N, Wolf J, Hoffmann W. DigiNet: Optimizing personalized care for patients with stage IV non-small cell lung cancer (NSCLC) through a digitally connected provider network-analysis plan of a prospective multicenter cohort trial. J Cancer Res Clin Oncol. 2025 Sep 9;151(9):244. doi: 10.1007/s00432-025-06275-x.
PMID: 40924208DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jürgen Wolf, Prof. Dr.
Uniklinik Köln
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Prof. Dr.
Study Record Dates
First Submitted
December 12, 2022
First Posted
April 18, 2023
Study Start
June 1, 2022
Primary Completion
March 31, 2025
Study Completion
March 31, 2025
Last Updated
June 4, 2024
Record last verified: 2024-06
Data Sharing
- IPD Sharing
- Will not share