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Non-small Cell Lung Cancer Stage IVDigiNetNCT05818449

Improvement of Personalized Lung Cancer Care Through Digital Connection and Patient Participation (DigiNet)

A study testing DigiNet intervention in people with Non-small Cell Lung Cancer Stage IV, run by University of Cologne at 41 sites in Germany.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Non-small Cell Lung Cancer Stage IV
What is being tested?
DigiNet intervention
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
850 participants
Where
41 sitesGermany
Study dates
1 Jun 2022to 31 Mar 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients diagnosed with advanced NSCLC, stage IV
  • Age > 18 years
  • Life expectancy at least 4 weeks (initial assessment at inclusion in nNGM and confirmation at baseline (implementation of treatment decision))

Who cannot join

  • 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

Trial locations and contacts

41 sites in 1 country.

41 sites in 1 country

Germany41 sites

  • Universitätsklinikum Aachen

    Aachen, North Rhine-Westphalia, 52074

  • Onkologie Erzgebirge

    Aue-Bad Schlema, Saxony, 08301

  • Hämatologisch-Onkologische Schwerpunktpraxis

    Bad Liebenwerda, Brandenburg, 04924

  • Hämatologisch Onkologisches Centrum Ostsachsen ONCOS GmbH

    Bautzen, Saxony, 02625

  • Charité Universitätsmedizin Berlin

    Berlin, 10117

  • Onkologische Schwerpunktpraxis Tiergarten

    Berlin, 10559

  • Onkologische Schwerpunktpraxis Kurfürstendamm

    Berlin, 10707

  • Praxis am Volkspark

    Berlin, 10715

  • Vivantes Klinikum Neukölln

    Berlin, 12351

  • Evangelische Lungenklinik Berlin

    Berlin, 13125

  • DRK Kliniken Berlin Mitte

    Berlin, 13359

  • Gemeinschaftskrankenhaus Havelhöhe

    Berlin, 14089

  • Helios Klinikum Emil von Behring

    Berlin, 14165

  • Onkologischer Schwerpunkt am Oskar-Helene-Heim

    Berlin, 14195

  • Johanniter-Krankenhaus Bonn

    Bonn, North Rhine-Westphalia, 53113

  • Onkozentrum Bonn

    Bonn, North Rhine-Westphalia, 53123

  • Universitätsklinikum Bonn (UKB)

    Bonn, North Rhine-Westphalia, 53127

  • Zentrum für ambulante Hämatologie und Onkologie Rhein-Sieg (ZAHO)

    Brühl, North Rhine-Westphalia, 50321

  • MV-Zentrum für Hämatologie und Onkologie

    Cologne, North Rhine-Westphalia, 50677

  • Universitätsklinikum Köln

    Cologne, North Rhine-Westphalia, 50937

  • MVZ West GmbH Standort Köln-Kalk

    Cologne, North Rhine-Westphalia, 51103

  • Praxis Internistischer Onkologie und Hämatologie (pioh)

    Cologne, North Rhine-Westphalia

  • Fachkrankenhaus Coswig

    Coswig, Saxony, 01640

  • Gemeinschaftspraxis für Hämatologie & Onkologie

    Dortmund, North Rhine-Westphalia, 44263

  • Gemeinschaftspraxis Dr. med. Johannes Mohm Dr. med. Gabriele Prange-Krex

    Dresden, Saxony, 01307

  • Gemeinschaftspraxis Hämatologie - Onkologie

    Dresden, Saxony, 01307

  • Universitätsklinikum Carl Gustav Carus Dresden

    Dresden, Saxony, 01307

  • Onkozentrum Dresden/Freiberg/Meißen

    Dresden/Freiberg/Meißen, Saxony

  • Helios Klinikum Erfurt

    Erfurt, Thuringia, 99089

  • Universitätsklinikum Essen

    Essen, North Rhine-Westphalia, 45147

  • Praxis für Hämatologie und Internistische Onkologie

    Hamm, North Rhine-Westphalia, 59065

  • Klinikum Leverkusen

    Leverkusen, North Rhine-Westphalia, 51375

  • Kliniken Maria Hilf GmbH

    Mönchengladbach, North Rhine-Westphalia, 41063

  • MVZ für Hämatologie und Onkologie

    Mülheim, North Rhine-Westphalia, 45468

  • Praxis und Tagesklinik für Internistische Onkologie und Hämatologie

    Recklinghausen, North Rhine-Westphalia, 45659

  • Krankenhaus Bethanien Solingen

    Solingen, North Rhine-Westphalia, 42699

  • Onkologie Rheinsieg

    Troisdorf/Bonn-Beuel/Bad Honnef, North Rhine-Westphalia, 53840

  • MVZ Medizinisches Versorgungszentrum am Marien-Hospital Wesel

    Wesel, North Rhine-Westphalia, 46483

  • Medizinisches Versorgungzentrum am Evangelischen Krankenhaus Wesel GmbH

    Wesel, North Rhine-Westphalia, 46485

  • Universitätsklinikum Würzburg

    Würzburg, Bavaria, 97080

  • Ambulante Onkologie Ostsachsen

    Zittau, Saxony, 02763

Other trials in Germany

About this study

Official title: 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)

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.

Read the detailed description

The aim of the DigiNet project is to prospectively evaluate a precision medicine program for lung cancer and to improve personalized care of patients with advanced non-small cell lung cancer (NSCLC) through a collaboration of specialized academic centers with routine care providers (hospitals, oncology practices). The use of targeted therapies will be regularly monitored and guided through a shared digital database. Patients with an initial diagnosis of stage IV NSCLC in the study regions (study region east: Berlin and Saxony; study region west: North Rhine-Westphalia) are included. DigiNet builds on the foundations and structures of the National Network Genomic Medicine Lung Cancer (nNGM) in Germany, which provides molecular diagnostics and treatment information to the participating physicians based on the latest evidence.

Within the framework of DigiNet, patients are regularly consulted by the study practitioners and the clinical data is documented in a structured manner in a central project database. Through the digital collaboration of the nNGM network centers via the shared project database with the practitioners in routine care, continuous monitoring of the course of treatment and, in the case of critical conditions, treatment guidance by an expert committee advising the practitioner is provided. In addition, the patients routinely assess the quality of life (EORTC QLQ-C30, EORTC QLQ-LC29, EQ-5D), as well as anxiety and depression (PHQ-4). The results of these patient-reported outcomes (PROs) are incorporated into the treatment by the practitioners (patient-centered treatment approach).

The evaluation of the project is structured into different core domains: An evaluation of clinical endpoints, process parameters (implementation of the intervention), and health economic evaluations will be conducted. The acceptance and potential for improvement of the project will be assessed through qualitative interviews with the stakeholders. Data from the state cancer registries of the study regions will be incorporated to generate a population-based comparative cohort for the evaluation of the main research questions of DigiNet, thereby representing patients receiving routine care in Germany.

Being tested
DigiNet intervention
Keywords
Carcinoma, Non-Small-Cell Lung, Carcinoma, Non-Small-Cell Lung* / diagnosis, Carcinoma, Non-Small-Cell Lung* / genetics, Precision Medicine, Pathology, Molecular, Patient Reported Outcome Measures, Database Management Systems
Medical subject headings
Carcinoma, Non-Small-Cell Lung, Carcinoma, Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DigiNet interventionOther

    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
Study groups in NCT05818449
Study groupRoleWhat they receive
DigiNet groupExperimentalThe intervention group will receive the DigiNet intervention.
Receives: Other: DigiNet intervention
Comparison groupNo interventionThe comparison group will receive usual care.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall Survival (OS)

    Overall Survival (OS) will be assessed in months.

    Measured: up to 34 months

Secondary outcomes (16)

  1. Progression-Free Survival (PFS)

    Progression-Free Survival (PFS) will be assessed in months.

    Measured: up to 34 months

  2. Time on First Treatment (ToT)

    Duration under first-line therapy will be assessed in months.

    Measured: up to 34 months

  3. Hospitalization rate

    Frequency of hospital stays will be assessed using health insurance data.

    Measured: up to 34 months

  4. Quality of Life (EORTC QLQ-C30)

    Quality of Life (European Organisation for Research and Treatment of Cancer, Quality of Life Core Questionnaire, EORTC QLQ-C30) will be assessed in absolute values and change over time. Each item is rated on a response scale 1 = "not at all" to 4 = "very much" with exception of the last two items, which assess overall health and quality of life on a scale from 1 = "very poor" to 7 = "excellent". All EORTC QLQ-C30 scale scores range from 0 to 100, whereby higher scores on a functional scale indicate a high level of functioning, whereas higher scores on a symptom scale/symptom item indicate greater symptom burden.

    Measured: up to 34 months

  5. Quality of Life (EORTC QLQ-LC29)

    Quality of Life (European Organisation for Research and Treatment of Cancer, Quality of Life Questionnaire Lung Cancer, EORTC QLQ-LC29) will be assessed in absolute values and change over time. Each item is rated on a response scale 1 = "not at all" to 4 = "very much" and refer to the time frame "during the past week". All EORTC QLQ-LC29 scale scores range from 0 to 100, whereby higher scores for a symptom scale/symptom item indicate greater symptom burden.

    Measured: up to 34 months

  6. Symptoms of anxiety (GAD-2)

    Symptoms of anxiety (Generalized Anxiety Disorder Scale-2, GAD-2) will be assessed in absolute values and change over time. Each item is rated on a response scale 0 = "not at all" to 3 = "nearly every day" and refer to the time frame "during the past two weeks". Higher scores indicate greater symptom burden.

    Measured: up to 34 months

  7. Symptoms of depression (PHQ-2)

    Symptoms of depression (Patient-Health-Questionnaire-2, PHQ-2) will be assessed in absolute values and change over time. Each item is rated on a response scale 0 = "not at all" to 3 = "nearly every day" and refer to the time frame "during the past two weeks". Higher scores indicate greater symptom burden.

    Measured: up to 34 months

  8. Frequency of applied targeted molecular therapies based on clinical therapy information from the MURIEL database

    The frequency of applied targeted molecular therapies is based on clinical therapy information from the MURIEL database.

    Measured: up to 34 months

  9. Frequency of active contact of the expert advisory board with physicians during the course of treatment

    Assessing the frequency of the expert advisory board actively contacting physicians during the course of treatment

    Measured: up to 34 months

  10. Completeness of the documentation of the treatment course

    Assessing the completeness of the documentation of the treatment course (DigiNet study visits) in %.

    Measured: up to 34 months

  11. Frequency of patients' completing the PROs

    Assessing the frequency of patients' completing the patient-reported outcomes (PRO) via the internet portal

    Measured: up to 34 months

  12. Cost-effectiveness of DigiNet compared to standard care in terms of incremental costs per life years gained

    Assessing the cost-effectiveness of DigiNet compared to standard care in terms of incremental costs per life years gained

    Measured: up to 34 months

  13. Cost-effectiveness of DigiNet compared to standard care in terms of costs per quality-adjusted life year [QALY]

    Assessing the cost-effectiveness of DigiNet compared to standard care in terms of costs per quality-adjusted life year [QALY]

    Measured: up to 34 months

  14. Cost of implementation related to DigiNet from the service provider perspective (hospital, practices)

    Assessing the cost of implementation related to DigiNet from the service provider perspective (hospital, practices) in Euro (€)

    Measured: up to 34 months

  15. Process costs related to DigiNet from the service provider perspective (hospital, practices)

    Assessing the process costs related to DigiNet from the service provider perspective (hospital, practices) in Euro (€)

    Measured: up to 34 months

  16. Formative evaluation

    Formative evaluation regarding the implementation will be conducted using qualitative analysis of semi-structured interviews

    Measured: up to 34 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Apr 2023
  2. Study start1 Jun 2022
  3. Primary completion31 Mar 2025 (estimated)
  4. Study completion31 Mar 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
850 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05818449
Sponsor's protocol ID
01NVF20021
Acronym
DigiNet
Status last verified
Jun 2024
First submitted
12 Dec 2022
Last updated
4 Jun 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 40924208

Questions about this trial

What is this clinical trial studying?

A study testing DigiNet intervention in people with Non-small Cell Lung Cancer Stage IV, run by University of Cologne at 41 sites in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 4 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 41 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Survival (OS) (time frame: up to 34 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05818449, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2024.

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