National PROspective Infrastructure for Renal Cell Carcinoma (PRO-RCC)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Renal Cancer, Renal Cell Carcinoma, Renal Cell Cancer Metastatic. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Netherlands
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
PROspective Renal Cancer Cohort (PRO-RCC)
Overview
PRO-RCC is a nationwide long-term cohort for the collection of real-world clinical data, patient reported outcome measures (PROMs) and patient reported experience measures (PREMs) that provides an infrastructure for observational research and (randomized) interventional studies with the TwiCs (Trial within cohorts) design.
Detailed description
PRO-RCC is designed as a multicenter cohort for all Dutch patients with localized RCC or metastatic renal cell carcinoma (mRCC). The clinical data collection is embedded in the framework of the Netherlands Cancer Registry (NCR). Next to the standardly available data on RCC, additional clinical data will be collected. The informed consent for PRO-RCC covers the online collection of PROMs and PREMS, data sharing and data linking with the NCR. PROMS entail Health-Related Quality of Life (HRQoL), and optional return to work- 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. Importantly, participants may also consent to participation in a 'Trial within cohort' studies (TwiC). The TwiC design provides a method to perform (randomized) studies within the registry.
Primary outcome measures
- survival [Time frame: 5 years]
- progression [Time frame: 5 years]
- patient reported outcome measures (PROMS) [Time frame: 5 years]
Secondary outcome measures (1)
- Patient reported outcomes of adverse events [Time frame: 2 years]
Eligibility criteria
Inclusion criteria
- newly diagnosed patients with RCC or synchronous metastatic RCC
- metachronous metastasized RCC
- age >18 years
- capable of understanding Dutch language
Exclusion criteria
- n/a
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Netherlands · 27 centers
- Amsterdam UMC locatie VUMC — Amsterdam
- Jeroen Bosch Ziekenhuis — 's-Hertogenbosch
- Jeroen Bosch Ziekenhuis — 's-Hertogenbosch
- Meander Medisch Centrum — Amersfoort
- Gelre ziekenhuis — Apeldoorn
- Rijnstate — Arnhem
- Amphia Ziekenhuis — Breda
- Deventer Ziekenhuis — Deventer
- … and 19 more centers
Publications
- Yildirim H, Widdershoven CV, Aarts MJ, Bex A, Bloemendal HJ, Bochove-Overgaauw DM, Hamberg P, Herbschleb KH, van der Hulle T, Lagerveld BW, van Oijen MG, Oosting SF, van Thienen JV, van der Veldt AA, Westgeest HM, Zeijdner EE, Aben KK, van den Hurk C, Zondervan PJ, Bins AD. The PRO-RCC study: a long-term PROspective Renal Cell Carcinoma cohort in the Netherlands, providing an infrastructure for 'T PMID 37434119
Identifiers
NCT: NCT05326620 · 2021_218