The PRO-RCC study: a long-term PROspective Renal Cell Carcinoma cohort in the Netherlands, providing an infrastructure for 'Trial within Cohorts' study designs.
Kidney cancer
Renal cell carcinoma
Urological cancer
Journal
BMC cancer
ISSN: 1471-2407
Titre abrégé: BMC Cancer
Pays: England
ID NLM: 100967800
Informations de publication
Date de publication:
11 Jul 2023
11 Jul 2023
Historique:
received:
19
01
2023
accepted:
21
06
2023
medline:
13
7
2023
pubmed:
12
7
2023
entrez:
11
7
2023
Statut:
epublish
Résumé
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.
Sections du résumé
BACKGROUND
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
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
BACKGROUND
Ethical board approval has been obtained (2021_218) and the study has been registered at ClinicalTrials.gov (NCT05326620).
DISCUSSION
CONCLUSIONS
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.
Identifiants
pubmed: 37434119
doi: 10.1186/s12885-023-11094-9
pii: 10.1186/s12885-023-11094-9
pmc: PMC10337109
doi:
Banques de données
ClinicalTrials.gov
['NCT05326620']
Types de publication
Multicenter Study
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
648Informations de copyright
© 2023. The Author(s).
Références
Cancer Immunol Immunother. 2021 Feb;70(2):265-273
pubmed: 32757054
Eur Urol Oncol. 2019 Nov;2(6):708-715
pubmed: 31588018
BMJ Open. 2021 May 18;11(5):e047256
pubmed: 34006553
Lancet Oncol. 2006 Feb;7(2):141-8
pubmed: 16455478
BMJ. 2010 Mar 19;340:c1066
pubmed: 20304934
Acta Oncol. 2016 Nov;55(11):1273-1280
pubmed: 27560599
JAMA Oncol. 2019 Dec 1;5(12):1769-1773
pubmed: 31158272
BMJ Open. 2021 Sep 13;11(9):e052494
pubmed: 34518276
Eur Urol. 2019 Jan;75(1):111-128
pubmed: 30467042
Cochrane Database Syst Rev. 2017 May 09;5:CD012045
pubmed: 28485814
J Natl Cancer Inst. 1993 Mar 3;85(5):365-76
pubmed: 8433390
Trials. 2015 Nov 03;16:495
pubmed: 26530985
Value Health. 2013 Jul-Aug;16(5):789-96
pubmed: 23947972
Eur Urol. 2019 Jan;75(1):74-84
pubmed: 30243799
J Clin Epidemiol. 2003 Dec;56(12):1163-9
pubmed: 14680666
BMJ Open. 2020 Aug 27;10(8):e034626
pubmed: 32859659
J Natl Cancer Inst. 2015 Dec 29;108(2):
pubmed: 26714555
Rev Urol. 2020;22(1):9-16
pubmed: 32523466
Eur Urol Oncol. 2020 Aug;3(4):433-452
pubmed: 32245655
J Clin Epidemiol. 2021 Feb;130:135-142
pubmed: 33130236
N Engl J Med. 2017 Jan 26;376(4):354-366
pubmed: 28121507
J Clin Oncol. 2010 Dec 10;28(35):5197-201
pubmed: 21060029
Patient. 2020 Oct;13(5):567-582
pubmed: 32508005
Clin Trials. 2021 Feb;18(1):104-114
pubmed: 33258687
Value Health. 2016 Jun;19(4):343-52
pubmed: 27325326
Nutr Cancer. 2017 Nov-Dec;69(8):1177-1184
pubmed: 29035593
Lancet. 2016 Feb 27;387(10021):894-906
pubmed: 26318520
Urol J. 2020 Mar 16;17(2):109-117
pubmed: 32180211
J Natl Cancer Inst. 2022 Jun 13;114(6):800-807
pubmed: 35201353
Annu Rev Clin Psychol. 2008;4:1-32
pubmed: 18509902