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Multicenter Study
. 2023 Jul 11;23(1):648.
doi: 10.1186/s12885-023-11094-9.

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  1   2 , Christiaan V Widdershoven  3 , Maureen Jb Aarts  4 , Axel Bex  5   6   7 , Haiko J Bloemendal  8 , Deirdre M Bochove-Overgaauw  9 , Paul Hamberg  10 , Karin H Herbschleb  11 , Tom van der Hulle  12 , Brunolf W Lagerveld  13 , Martijn Gh van Oijen  14 , Sjoukje F Oosting  15 , Johannes V van Thienen  16 , Astrid Am van der Veldt  17 , Hans M Westgeest  18 , Evelijn E Zeijdner  19 , Katja Kh Aben #  20   21 , Corina van den Hurk #  20 , Patricia J Zondervan #  3 , Adriaan D Bins #  14
Affiliations
Multicenter Study

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 et al. BMC Cancer. .

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.

Keywords: Kidney cancer; Renal cell carcinoma; Urological cancer.

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Conflict of interest statement

SFO reports research grants from Novartis and Celldex Therapeutics, and consultancy fees from Bristol Myers Squibb (all paid to the institution) outside the submitted work. HMW reports personal fees from Ipsen, Astellas and Roche outside the submitted work. Other authors have no competing interests to declare.

Figures

Fig. 1
Fig. 1
The ‘Trial within Cohorts’ design (TwiCs). After ethical approval for an interventional TwiCs study, eligible patients are selected from the cohort. Only patients who have given informed consent for potential participation in TwiCs upon entry in the PRO-RCC cohort are eligible for selection. After selection, eligible patients are randomized to the control or the intervention arm. Before inclusion in the intervention arm, separate informed consent has to be obtained from each patient. Patients in the control arm receive standard of care similar to the rest of the cohort and do not receive additional information. These patients have consented not to be notified of randomization in a TwiCs control arm, as part of their consent to TwiCs participation upon entry in the PRO-RCC cohort
Fig. 2
Fig. 2
Overview of the collected patient reported oucome- and expierence measures over time. T = Time, FU = Follow-up
See this image and copyright information in PMC

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References

    1. Capitanio U, Bensalah K, Bex A, Boorjian SA, Bray F, Coleman J, et al. Epidemiology of renal cell carcinoma. Eur Urol. 2019;75:74–84. doi: 10.1016/j.eururo.2018.08.036. - DOI - PMC - PubMed
    1. Netherlands Cancer Registry. https://iknl.nl/en/ncr. Accessed 2 Jun 2021.
    1. Capitanio U, Montorsi F. Renal cancer. The Lancet. 2016;387:894–906. doi: 10.1016/S0140-6736(15)00046-X. - DOI - PubMed
    1. Bhindi B, Abel EJ, Albiges L, Bensalah K, Boorjian SA, Daneshmand S, et al. Systematic review of the role of Cytoreductive Nephrectomy in the targeted therapy era and Beyond: an Individualized Approach to metastatic renal cell carcinoma. Eur Urol. 2019;75:111–28. doi: 10.1016/j.eururo.2018.09.016. - DOI - PubMed
    1. Yang Y. Partial Versus Radical Nephrectomy in patients with renal cell carcinoma: a systematic review and Meta-analysis. Urol J. 2020;17:109–17. - PubMed

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