Introduction Translational research is important, especially in medicine where decisions affect people's lives. Clinical reg-istries and the studies embedded in them allow the depiction of actual care practice under routine conditions. Translating the findings of health services research back into clinical research through prospective cohort studies has the potential to drive medical innovations faster, more effectively and, above all, in a more targeted manner. These must therefore be a central component of cutting-edge oncological research. Objective The aim of the registry is the establishment of clinical cohorts and the provision of a comprehensive, highquality data set for oncological diseases. Methods/Design The registry will prospectively record all patients treated for cancer at Dresden University Hospital (UKD). In addition to the data from the hospital information systems (ORBIS, TDS, GEPADO, etc.), monitoring of healthrelated quality of life (HRQOL) is to be carried out at regular intervals at the beginning and during the course of treatment. In addition, individual linkage with data from clinical cancer registries and health insurance companies (including AOK PLUS) is planned for a period of five years before and after inclusion. All these data will be merged in a registry database. The selection of variables and measurement time points is closely based on the guidelines for colorectal carcinoma of the international initiative ICHOM (International Consortium for Health Outcomes Measurement). The study management software (STeVe) separates personal identification characteristics (IDAT) and medical data (MDAT) at an early stage. The independent trust centre of the TU Dresden (Treuhandstelle) ensures that no personal data enter the registry database. It is thereby also ensured that the data owners involved (UKD, biobank, health insurance company, cancer registry, patient) only receive the personal data they need for allocation. The MOSAIC software tools recommended by the TMF (Technologie- und Methodenplattform f r die vernetzte medizinische Forschung e.V.) are used to manage the pseudonyms. Discussion/Conclusion With the registry, previously missing evidence on the effectiveness, safety and costs of diagnostic and therapeutic measures can be made, taking into account long-term and patient-reported outcomes of routine care. The data potentially allow for the identification of barriers to and facilitators of innovative promising cancer diagnostics and therapies. They also enable generation of scientifically relevant hypotheses in the field of translational and outcomes research.
|Translated title of the contribution
Long-term observation of patients with cancer an entityindependent registry for healthcare and translational research at the University Medicine Dresden (Cancer-Reg-VT)
|Published - 26 Sept 2023
Sustainable Development Goals
ASJC Scopus subject areas
- Cancer diseases, Data linkage, HRQOL, SHI data, Humans, Quality of Life, Translational Research, Biomedical, Prospective Studies, Germany/epidemiology, Registries, Delivery of Health Care, Neoplasms/diagnosis