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

Renal Cell Carcinoma Clinical Trial

— PRO-RCC  

Official title:

PROspective Renal Cancer Cohort (PRO-RCC)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05326620
• Other study ID #: 2021_218
• Status: Recruiting
• Start date: January 19, 2023
• Est. completion date: January 2030

Study information

• Verified date: January 2024
• Source: PROspective Renal Cancer Cohort Foundation
• Contact: Hilin Yildirim, MD
• Phone: 0031643202583
• Email: h.yildirim[@]iknl.nl
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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) design.

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), 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2000
• Est. completion date: January 2030
• Est. primary completion date: January 2030
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Renal Cell
• Kidney Neoplasms
• Renal Cancer
• Renal Cell Cancer Metastatic
• Renal Cell Carcinoma

Locations

Country	Name	City	State
Netherlands	Jeroen Bosch Ziekenhuis	's-Hertogenbosch
Netherlands	Meander Medisch Centrum	Amersfoort
Netherlands	Amsterdam UMC locatie VUMC	Amsterdam	Noord Holland
Netherlands	Amphia Ziekenhuis	Breda
Netherlands	Deventer Ziekenhuis	Deventer
Netherlands	Treant	Emmen
Netherlands	UMCG	Groningen
Netherlands	Maastricht UMC	Maastricht
Netherlands	St Antonius Ziekenhuis	Nieuwegein
Netherlands	Bravis ziekenhuis	Roosendaal

Sponsors (5)

Lead Sponsor	Collaborator
PROspective Renal Cancer Cohort Foundation	Bristol-Myers Squibb, Comprehensive Cancer Centre The Netherlands, Ipsen, Merck Sharp & Dohme LLC

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	survival	overall survival	5 years
Primary	progression	local or distant recurrence	5 years
Primary	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.	5 years
Secondary	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)	2 years

External Links

•   official study and foundation website