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

Recruiting

• Conditions: Renal Cancer; Renal Cell Carcinoma; Renal Cell Cancer Metastatic

• Registration Number: NCT05326620
• Lead Sponsor: PROspective Renal Cancer Cohort Foundation

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.

Study Timeline

• Study First Submitted: 2022-03-17
• Study First Submitted QC: 2022-04-06
• Study First Posted: 2022-04-13
• Study Start: 2023-01-19
• Status Verified: 2025-06
• Last Update Submitted: 2025-06-03
• Last Update Posted: 2025-06-06
• Primary Completion: 2030-01
• Study Completion: 2030-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 2000

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
progression	5 years	local or distant recurrence
patient reported outcome measures (PROMS)	5 years	measured with the EORTC QLQ-C30 questionnaire, every three months in the first year, then yearly up to five years.
survival	5 years	overall survival

Secondary Outcome Measures

Name	Time	Method
Patient reported outcomes of adverse events	2 years	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)

Trial Locations

Locations (26)

Gelre ziekenhuis; 🇳🇱 Apeldoorn, Netherlands

Rijnstate; 🇳🇱 Arnhem, Netherlands

Haaglanden Medisch Centrum; 🇳🇱 Den Haag, Netherlands

Albert Schweitzer; 🇳🇱 Dordrecht, Netherlands

Catharina ziekenhuis; 🇳🇱 Eindhoven, Netherlands

Maxima MC; 🇳🇱 Eindhoven, Netherlands

Spaarne Gasthuis; 🇳🇱 Haarlem, Netherlands

Tergooi MC; 🇳🇱 Hilversum, Netherlands

Medisch Centrum Leeuwarden; 🇳🇱 Leeuwarden, Netherlands

Canisius Wilhelmina Ziekenhuis; 🇳🇱 Nijmegen, Netherlands

Scroll for more (16 remaining)