Clinical trial NCT05326620: National PROspective Infrastructure for Renal Cell Carcinoma (PRO-RCC)
Official title: PROspective Renal Cancer Cohort (PRO-RCC)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Renal Cancer
Renal Cell Carcinoma
Renal Cell Cancer Metastatic
Lead sponsor: PROspective Renal Cancer Cohort Foundation
Sponsor class: OTHER
Collaborators: name: Comprehensive Cancer Centre The Netherlands
name: Merck Sharp & Dohme LLC
name: Bristol-Myers Squibb
name: Ipsen
name: Pfizer
First posted: 2022-04-13
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: all patients with newly diagnosed (m)RCC can be included, or with synchronous metastasized RCC

Brief 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) 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.

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

Primary outcomes:
measure: survival
timeFrame: 5 years
measure: progression
timeFrame: 5 years
measure: patient reported outcome measures (PROMS)
timeFrame: 5 years
Secondary outcomes:
measure: Patient reported outcomes of adverse events
timeFrame: 2 years
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: Amsterdam UMC locatie VUMC
state: Noord Holland
city: 's-Hertogenbosch
country: Netherlands
facility: Jeroen Bosch Ziekenhuis
city: Amersfoort
country: Netherlands
facility: Meander Medisch Centrum
city: Apeldoorn
country: Netherlands
facility: Gelre ziekenhuis
city: Arnhem
country: Netherlands
facility: Rijnstate
city: Breda
country: Netherlands
facility: Amphia Ziekenhuis
city: Den Bosch
country: Netherlands
facility: Jeroen Bosch Ziekenhuis
city: Den Haag
country: Netherlands
facility: Haaglanden Medisch Centrum
city: Deventer
country: Netherlands
facility: Deventer Ziekenhuis
city: Dordrecht
country: Netherlands
facility: Albert Schweitzer
city: Eindhoven
country: Netherlands
facility: Catharina ziekenhuis
city: Eindhoven
country: Netherlands
facility: Maxima MC
city: Emmen
country: Netherlands
facility: Treant
city: Groningen
country: Netherlands
facility: UMCG
city: Haarlem
country: Netherlands
facility: Spaarne Gasthuis
city: Hilversum
country: Netherlands
facility: Tergooi MC
city: Leeuwarden
country: Netherlands
facility: Medisch Centrum Leeuwarden
city: Maastricht
country: Netherlands
facility: Maastricht UMC
city: Nieuwegein
country: Netherlands
facility: St Antonius Ziekenhuis
city: Nijmegen
country: Netherlands
facility: Canisius Wilhelmina Ziekenhuis
city: Roosendaal
country: Netherlands
facility: Bravis ziekenhuis
city: Rotterdam
country: Netherlands
facility: Erasmus MC
city: Rotterdam
country: Netherlands
facility: Maasstad ziekenhuis
city: Rotterdam
country: Netherlands
facility: St. Franciscus ziekenhuis
city: Utrecht
country: Netherlands
facility: UMC Utrecht
city: Venray
country: Netherlands
facility: Viecuri
city: Zwolle
country: Netherlands
facility: Isala
Study officials:
affiliation: Amsterdam UMC
name: Adriaan Bins, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: