Long-Term Observation of Patients With Cancer – an Entity-Independent Registry for Healthcare and Translational Research at the University Medicine Dresden (Cancer-Reg-VT)

Abstract

Introduction Translational research is important, especially in medicine where decisions affect people’s lives. Clinical registries 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, high-quality 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 health-related 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 für 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.

Key words

Cancer diseases - Data linkage - SHI data - HRQOL

• Literatur

• 1 Westfall JM, Mold J, Fagnan L. Practice-Based Research—“Blue Highways” on the NIH Roadmap. JAMA 2007; 297: 403-406
• 2 Domenghino A, Walbert C, Birrer DL. et al. Consensus recommendations on how to assess the quality of surgical interventions. Nature Medicine 2023; 29: 811-822
• 3 Zerillo JA, Schouwenburg MG, van Bommel ACM. et al. An International Collaborative Standardizing a Comprehensive Patient-Centered Outcomes Measurement Set for Colorectal Cancer. JAMA Oncol 2017; 3: 686-694
• 4 Hanahan D. Rethinking the war on cancer. Lancet (London, England) 2014; 383: 558-563
• 5 Lowy DR, Collins FS. Aiming High--Changing the Trajectory for Cancer. The New England journal of medicine 2016; 374: 1901-1904
• 6 Swart E, Gothe H, Geyer S. et al. Gute Praxis Sekundärdatenanalyse (GPS): Leitlinien und Empfehlungen. Gesundheitswesen 2015; 77: 120-126
• 7 March S, Andrich S, Drepper J. et al. Gute Praxis Datenlinkage (GPD). Gesundheitswesen 2019; 81: 636-650
• 8 Deutsche Gesellschaft für Epidemioloige (DGEpi). Leitlinien und Empfehlungen zur Sicherung von Guter Epidemiologischer Praxis (GEP). 2004
• 9 World Medical Association. Declaration of Helsinki: ethical principles for medical research involving human subjects. JAMA 2013; 310: 2191-2194
• 10 Hu ZH, Connett JE, Yuan JM. et al. Role of survivor bias in pancreatic cancer case-control studies. Annals of epidemiology 2016; 26: 50-56
• 11 Aaronson NK, Ahmedzai S, Bergman B. et al. The European Organization for Research and Treatment of Cancer QLQ-C30: a quality-of-life instrument for use in international clinical trials in oncology. Journal of the National Cancer Institute 1993; 85: 365-376