The PRO-RCC study: a long-term PROspective Renal Cell Carcinoma cohort in the Netherlands, providing an infrastructure for ‘Trial within Cohorts’ study designs
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
Affiliations
Hilin Yildirim
Department of Research and Development, Netherlands Comprehensive Cancer Organisation
Christiaan V Widdershoven
Department of Urology, Amsterdam UMC location University of Amsterdam
Maureen JB Aarts
Department of Medical Oncology, GROW-School for Oncology and Development Biology, Maastricht University Medical Centre+
Axel Bex
Department of Urology, The Netherlands Cancer Institute, Antoni van Leeuwenhoek Hospital
Haiko J Bloemendal
Department of Oncology, Radboud University Medical Centre
Deirdre M Bochove-Overgaauw
Department of Urology, Gelre Hospitals
Paul Hamberg
Department of Internal Medicine, Franciscus Gasthuis & Vlietland
Karin H Herbschleb
Department of Internal Medicine, St. Antonius Ziekenhuis
Tom van der Hulle
Department of Medical Oncology, LUMC
Brunolf W Lagerveld
Department of Urology, OLVG
Martijn GH van Oijen
Department of Medical Oncology, Cancer Center Amsterdam, Amsterdam UMC location University of Amsterdam
Sjoukje F Oosting
Department of Medical Oncology, University Medical Center Groningen, University of Groningen
Johannes V van Thienen
Department of Medical Oncology, Netherlands Cancer Institute, Antoni van Leeuwenhoek hospital
Astrid AM van der Veldt
Department of Medical Oncology, Department of Radiology & Nuclear Medicine, Erasmus Medical Center-Cancer Institute
Hans M Westgeest
Department of Internal Medicine, Amphia Hospital
Evelijn E Zeijdner
Dutch Oncology Research Platform
Katja KH Aben
Department of Research and Development, Netherlands Comprehensive Cancer Organisation
Corina van den Hurk
Department of Research and Development, Netherlands Comprehensive Cancer Organisation
Patricia J Zondervan
Department of Urology, Amsterdam UMC location University of Amsterdam
Adriaan D Bins
Department of Medical Oncology, Cancer Center Amsterdam, Amsterdam UMC location University of Amsterdam
Abstract Background 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). Methods 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. Trial registration Ethical board approval has been obtained (2021_218) and the study has been registered at ClinicalTrials.gov (NCT05326620). Discussion 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.
