Ongoing research in the field of both localized, locally advanced and metastatic renal cell carcinoma has resulted in the availability of multiple treatment options. Hence, many questions are still unanswered and await further research. A nationwide collaborative registry allows to collect corresponding data. For this purpose, the Dutch PROspective Renal Cell Carcinoma cohort (PRO-RCC) has been founded, for the prospective collection of long-term clinical data, patient reported outcome measures (PROMs) and patient reported experience measures (PREMs).
PRO-RCC is designed as a multicenter cohort for all Dutch patients with renal cell carcinoma (RCC). Recruitment will start in the Netherlands in 2023. Importantly, participants may also consent to participation in a 'Trial within cohorts' studies (TwiCs). The TwiCs design provides a method to perform (randomized) interventional studies within the registry. The clinical data collection is embedded in the Netherlands Cancer Registry (NCR). Next to the standardly available data on RCC, additional clinical data will be collected. PROMS entail Health-Related Quality of Life (HRQoL), symptom monitoring with optional ecological momentary assessment (EMA) of pain and fatigue, and optional return to work- and/or nutrition questionnaires. PREMS entail satisfaction with care. Both PROMS and PREMS are collected through the PROFILES registry and are accessible for the patient and the treating physician.
Ethical board approval has been obtained (2021_218) and the study has been registered at ClinicalTrials.gov (NCT05326620).
PRO-RCC is a nationwide long-term cohort for the collection of real-world clinical data, PROMS and PREMS. By facilitating an infrastructure for the collection of prospective data on RCC, PRO-RCC will contribute to observational research in a real-world study population and prove effectiveness in daily clinical practice. The infrastructure of this cohort also enables that interventional studies can be conducted with the TwiCs design, without the disadvantages of classic RCTs such as slow patient accrual and risk of dropping out after randomization.
BMC cancer. 2023 Jul 11*** epublish ***
Hilin Yildirim, Christiaan V Widdershoven, Maureen Jb Aarts, Axel Bex, Haiko J Bloemendal, Deirdre M Bochove-Overgaauw, Paul Hamberg, Karin H Herbschleb, Tom van der Hulle, Brunolf W Lagerveld, Martijn Gh van Oijen, Sjoukje F Oosting, Johannes V van Thienen, Astrid Am van der Veldt, Hans M Westgeest, Evelijn E Zeijdner, Katja Kh Aben, Corina van den Hurk, Patricia J Zondervan, Adriaan D Bins
Department of Research and Development, Netherlands Comprehensive Cancer Organisation, Utrecht, The Netherlands. ., Department of Urology, Amsterdam UMC location University of Amsterdam, Amsterdam, The Netherlands., Department of Medical Oncology, GROW-School for Oncology and Development Biology, Maastricht University Medical Centre+, Maastricht, the Netherlands., Department of Urology, The Netherlands Cancer Institute, Antoni van Leeuwenhoek Hospital, Amsterdam, The Netherlands., Department of Oncology, Radboud University Medical Centre, Nijmegen, The Netherlands., Department of Urology, Gelre Hospitals, Apeldoorn/Zutphen, The Netherlands., Department of Internal Medicine, Franciscus Gasthuis & Vlietland, Rotterdam/Schiedam, the Netherlands., Department of Internal Medicine, St. Antonius Ziekenhuis, Nieuwegein, The Netherlands., Department of Medical Oncology, LUMC, Leiden, the Netherlands., Department of Urology, OLVG, Amsterdam, The Netherlands., Department of Medical Oncology, Cancer Center Amsterdam, Amsterdam UMC location University of Amsterdam, 4F De Boelelaan 1117, Amsterdam, 1081 HV, The Netherlands., Department of Medical Oncology, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands., Department of Medical Oncology, Netherlands Cancer Institute, Antoni van Leeuwenhoek hospital, Amsterdam, The Netherlands., Department of Medical Oncology, Department of Radiology & Nuclear Medicine, Erasmus Medical Center-Cancer Institute, Rotterdam, the Netherlands., Department of Internal Medicine, Amphia Hospital, Breda, the Netherlands., Dutch Oncology Research Platform, Utrecht, The Netherlands., Department of Research and Development, Netherlands Comprehensive Cancer Organisation, Utrecht, The Netherlands.