Renal CancerPRO-RCCNCT05326620
National PROspective Infrastructure for Renal Cell Carcinoma (PRO-RCC)
An observational study of Renal Cancer and Renal Cell Carcinoma, run by PROspective Renal Cancer Cohort Foundation at 27 sites in Netherlands.
Trial summary
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)… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Cancer, Renal Cell Carcinoma, Renal Cell Cancer Metastatic
- How many people
- 2,000 participants
- Where
- 27 sitesNetherlands
- Study dates
- 19 Jan 2023to Jan 2030
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: all patients with newly diagnosed (m)RCC can be included, or with synchronous metastasized RCC
Who may be able to join
- newly diagnosed patients with RCC or synchronous metastatic RCC
- metachronous metastasized RCC
- age >18 years
- capable of understanding Dutch language
Who cannot join
- n/a
Trial locations and contacts
27 sites in 1 country. Contact the study team or a site near you to ask about taking part.
27 sites in 1 country
Netherlands27 sites, 27 recruiting
- Recruiting
Jeroen Bosch Ziekenhuis
's-Hertogenbosch
T Smilde
- Recruiting
Jeroen Bosch Ziekenhuis
's-Hertogenbosch
Saskia van der Meer, MD PhD
- Recruiting
Meander Medisch Centrum
Amersfoort
JM van Dodewaard
- Recruiting
Amsterdam UMC locatie VUMC
Amsterdam, North Holland
A.D. Bins
- Recruiting
Gelre ziekenhuis
Apeldoorn
D. Bochove
- Recruiting
Rijnstate
Arnhem
M. van den Berg
- Recruiting
Amphia Ziekenhuis
Breda
H Westgeest
- Recruiting
Deventer Ziekenhuis
Deventer
A Imholz
- Recruiting
Albert Schweitzer
Dordrecht
J. van den Bosch
- Recruiting
Catharina ziekenhuis
Eindhoven
W Scheepens
- Recruiting
Maxima MC
Eindhoven
M. Dercksen
- Recruiting
Treant
Emmen
B Knipscheer
- Recruiting
UMCG
Groningen
S Oosting
- Recruiting
Spaarne Gasthuis
Haarlem
S Dijkstra
- Recruiting
Tergooi MC
Hilversum
H.P. van den Berg
- Recruiting
Medisch Centrum Leeuwarden
Leeuwarden
B Rikhof
- Recruiting
Maastricht UMC
Maastricht
MJB Essers Aarts
- Recruiting
St Antonius Ziekenhuis
Nieuwegein
K Herbschleb
- Recruiting
Canisius Wilhelmina Ziekenhuis
Nijmegen
S Dijkstra
- Recruiting
Bravis ziekenhuis
Roosendaal
E Collette
- Recruiting
Erasmus MC
Rotterdam
Paul Verhagen
- Recruiting
Maasstad ziekenhuis
Rotterdam
Haberkorn
- Recruiting
St. Franciscus ziekenhuis
Rotterdam
R Soest
- Recruiting
Haaglanden Medisch Centrum
The Hague
L. de Vries
- Recruiting
UMC Utrecht
Utrecht
- Recruiting
Viecuri
Venray
Tom Hermans, MD, PhD
- Recruiting
Isala
Zwolle
M. Steffens
About this study
Official title: PROspective Renal Cancer Cohort (PRO-RCC)
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.
Read the 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.
- Medical subject headings
- Kidney Neoplasms, Carcinoma, Renal Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| localized RCC | all patients with localized RCC | |
| metastatic RCC | all patients with metastatic RCC, synchronous or metachronous |
What is being measured
The primary outcome is the main question the study is designed to answer.
survival
overall survival
Measured: 5 years
progression
local or distant recurrence
Measured: 5 years
patient reported outcome measures (PROMS)
measured with the EORTC QLQ-C30 questionnaire, every three months in the first year, then yearly up to five years.
Measured: 5 years
Secondary outcomes (1)
Patient reported outcomes of adverse events
Measured with the PRO-CTCAE (patient-reported outcomes version of the common terminology criteria for adverse events), weekly during systemic therapy. Symptoms are scored through 0 (absent) to 3 (severe)
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2022
- Study start19 Jan 2023
- Primary completionJan 2030 (estimated)
- Study completionJan 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Renal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,000 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- PROspective Renal Cancer Cohort Foundation
- Sponsor type
- University, hospital or other
- Collaborators
- Comprehensive Cancer Centre The Netherlands, Merck Sharp & Dohme LLC, Bristol-Myers Squibb, Ipsen, Pfizer
- Responsible party
- Sponsor
- Investigators
- Adriaan Bins, MD, PhD, Principal investigator, Amsterdam UMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05326620
- Sponsor's protocol ID
- 2021_218
- Acronym
- PRO-RCC
- Status last verified
- Jun 2025
- First submitted
- 17 Mar 2022
- Last updated
- 6 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 'Trial within Cohorts' study designs. BMC Cancer. 2023 Jul 11;23(1):648. doi: 10.1186/s12885-023-11094-9.
PubMed 37434119
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PROspective Renal Cancer Cohort (PRO-RCC)
- ClinicalTrials.gov ID
- NCT05326620
- Acronym / sponsor ID
- PRO-RCC / 2021_218
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- PROspective Renal Cancer Cohort FoundationUniversity, hospital or other
- Collaborators
- Comprehensive Cancer Centre The Netherlands, Merck Sharp & Dohme LLC, Bristol-Myers Squibb, Ipsen, Pfizer
- Study start
- 19 Jan 2023 (actual)
- Primary completion
- Jan 2030 (estimated)
- Study completion
- Jan 2030 (estimated)
- First posted
- 13 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| localized RCC | – | –all patients with localized RCC |
| metastatic RCC | – | –all patients with metastatic RCC, synchronous or metachronous |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- all patients with newly diagnosed (m)RCC can be included, or with synchronous metastasized RCC
Key inclusion criteria (4 listed)
- newly diagnosed patients with RCC or synchronous metastatic RCC
- metachronous metastasized RCC
- age >18 years
- capable of understanding Dutch language
Key exclusion criteria (1 listed)
- n/a
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
survival
Time frame: 5 years
overall survival
progression
Time frame: 5 years
local or distant recurrence
patient reported outcome measures (PROMS)
Time frame: 5 years
measured with the EORTC QLQ-C30 questionnaire, every three months in the first year, then yearly up to five years.
1 secondary outcome
Patient reported outcomes of adverse events
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2025.
- Derived from this study: PubMed 37434119Yildirim 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 'Trial within Cohorts' study designs. BMC Cancer. 2023 Jul 11;23(1):648. doi: 10.1186/s12885-023-11094-9.
- official study and foundation websiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Renal Cancer
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
Active, not recruitingPhase 3
A Study of Belzutifan (MK-6482) in Combination With Lenvatinib Versus Cabozantinib for Treatment of Renal Cell Carcinoma (MK-6482-011)
Carcinoma, Renal Cell
RecruitingPhase 2/3
Testing the Role of DNA Released From Tumor Cells Into the Blood in Guiding the Use of Immunotherapy After Surgical Removal of the Bladder, Kidney, Ureter, and Urethra for Urothelial Cancer Treatment, MODERN Study
Muscle Invasive Bladder Urothelial Carcinoma, Muscle Invasive Renal Pelvis Urothelial Carcinoma
Not yet recruitingPhase 2
Toripalimab and Lenvatinib With or Without SBRT Before Surgery for Non-Clear Cell Kidney Cancer
Nonmetastatic Locally Advanced Non-Clear Cell Renal Cell Carcinoma
Not yet recruitingPhase 1
A Study to Assess the Pharmacokinetics and Safety of Revumenib in Participants With Advanced Cancer and Hepatic or Renal Impairment
Relapsed/Refractory (R/R) Hematologic Malignancies, Acute Leukemia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Adriaan Bins, MD, PhD principal investigator
Amsterdam UMC
27 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Renal Cancer and Renal Cell Carcinoma, run by PROspective Renal Cancer Cohort Foundation at 27 sites in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 27 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hilin Yildirim, MD (0031643202583, h.yildirim@iknl.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
survival (time frame: 5 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05326620, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jun 2025.