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

NCT05818449 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 850

Last updated 2024-06-04

No results posted yet for this study

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.

Conditions

  • Non-small Cell Lung Cancer Stage IV

Interventions

OTHER

DigiNet intervention

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

Sponsors & Collaborators

  • Gemeinsamer Bundesausschuss (G-BA)

    collaborator UNKNOWN
  • AOK Rheinland/Hamburg

    collaborator INDUSTRY
  • AOK Nordwest

    collaborator INDUSTRY
  • BARMER

    collaborator OTHER
  • University Hospital, Essen

    collaborator OTHER
  • Charite University, Berlin, Germany

    collaborator OTHER
  • Berlin Institute of Health

    collaborator OTHER
  • Helios Klinikum Emil von Behring

    collaborator UNKNOWN
  • University Hospital Carl Gustav Carus

    collaborator OTHER
  • Deutsche Krebsgesellschaft e.V.

    collaborator OTHER
  • Berufsverband der Niedergelassenen Hämatologen und Onkologen in Deutschland e.V.

    collaborator UNKNOWN
  • AOK Bundesverband

    collaborator UNKNOWN
  • FOM Hochschule für Oekonomie und Management

    collaborator UNKNOWN
  • University Medicine Greifswald

    collaborator OTHER
  • Technische Universität Dresden

    collaborator OTHER
  • University of Cologne

    lead OTHER

Principal Investigators

  • Jürgen Wolf, Prof. Dr. · Uniklinik Köln

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-06-01
Primary Completion
2025-03-31
Completion
2025-03-31

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05818449 on ClinicalTrials.gov