National PROspective Infrastructure for Renal Cell Carcinoma (PRO-RCC)

NCT ID: NCT05326620

Last Updated: 2025-06-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

2000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-01-19

Study Completion Date

2030-01-31

Brief Summary

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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

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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.

Conditions

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Renal Cancer Renal Cell Carcinoma Renal Cell Cancer Metastatic

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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localized RCC

all patients with localized RCC

No interventions assigned to this group

metastatic RCC

all patients with metastatic RCC, synchronous or metachronous

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Comprehensive Cancer Centre The Netherlands

OTHER

Sponsor Role collaborator

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role collaborator

Bristol-Myers Squibb

INDUSTRY

Sponsor Role collaborator

Ipsen

INDUSTRY

Sponsor Role collaborator

Pfizer

INDUSTRY

Sponsor Role collaborator

PROspective Renal Cancer Cohort Foundation

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Adriaan Bins, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Amsterdam UMC

Locations

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Amsterdam UMC locatie VUMC

Amsterdam, North Holland, Netherlands

Site Status RECRUITING

Jeroen Bosch Ziekenhuis

's-Hertogenbosch, , Netherlands

Site Status RECRUITING

Jeroen Bosch Ziekenhuis

's-Hertogenbosch, , Netherlands

Site Status RECRUITING

Meander Medisch Centrum

Amersfoort, , Netherlands

Site Status RECRUITING

Gelre ziekenhuis

Apeldoorn, , Netherlands

Site Status RECRUITING

Rijnstate

Arnhem, , Netherlands

Site Status RECRUITING

Amphia Ziekenhuis

Breda, , Netherlands

Site Status RECRUITING

Deventer Ziekenhuis

Deventer, , Netherlands

Site Status RECRUITING

Albert Schweitzer

Dordrecht, , Netherlands

Site Status RECRUITING

Catharina ziekenhuis

Eindhoven, , Netherlands

Site Status RECRUITING

Maxima MC

Eindhoven, , Netherlands

Site Status RECRUITING

Treant

Emmen, , Netherlands

Site Status RECRUITING

UMCG

Groningen, , Netherlands

Site Status RECRUITING

Spaarne Gasthuis

Haarlem, , Netherlands

Site Status RECRUITING

Tergooi MC

Hilversum, , Netherlands

Site Status RECRUITING

Medisch Centrum Leeuwarden

Leeuwarden, , Netherlands

Site Status RECRUITING

Maastricht UMC

Maastricht, , Netherlands

Site Status RECRUITING

St Antonius Ziekenhuis

Nieuwegein, , Netherlands

Site Status RECRUITING

Canisius Wilhelmina Ziekenhuis

Nijmegen, , Netherlands

Site Status RECRUITING

Bravis ziekenhuis

Roosendaal, , Netherlands

Site Status RECRUITING

Erasmus MC

Rotterdam, , Netherlands

Site Status RECRUITING

Maasstad ziekenhuis

Rotterdam, , Netherlands

Site Status RECRUITING

St. Franciscus ziekenhuis

Rotterdam, , Netherlands

Site Status RECRUITING

Haaglanden Medisch Centrum

The Hague, , Netherlands

Site Status RECRUITING

UMC Utrecht

Utrecht, , Netherlands

Site Status RECRUITING

Viecuri

Venray, , Netherlands

Site Status RECRUITING

Isala

Zwolle, , Netherlands

Site Status RECRUITING

Countries

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Netherlands

Central Contacts

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Hilin Yildirim, MD

Role: CONTACT

0031643202583

Facility Contacts

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A.D. Bins

Role: primary

T Smilde

Role: primary

Saskia van der Meer, MD PhD

Role: primary

JM van Dodewaard

Role: primary

D. Bochove

Role: primary

M. van den Berg

Role: primary

H Westgeest

Role: primary

A Imholz

Role: primary

J. van den Bosch

Role: primary

W Scheepens

Role: primary

M. Dercksen

Role: primary

B Knipscheer

Role: primary

S Oosting

Role: primary

S Dijkstra

Role: primary

H.P. van den Berg

Role: primary

B Rikhof

Role: primary

MJB Essers Aarts

Role: primary

K Herbschleb

Role: primary

S Dijkstra

Role: primary

E Collette

Role: primary

Paul Verhagen

Role: primary

Haberkorn

Role: primary

R Soest

Role: primary

L. de Vries

Role: primary

Tom Hermans, MD, PhD

Role: primary

M. Steffens

Role: primary

References

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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.

Reference Type DERIVED
PMID: 37434119 (View on PubMed)

Related Links

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http://www.pro-rcc.nl

official study and foundation website

Other Identifiers

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2021_218

Identifier Type: -

Identifier Source: org_study_id

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