NCT05326620

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

PROspective Renal Cancer Cohort (PRO-RCC)

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 2,000 (estimated)
• Sponsor: PROspective Renal Cancer Cohort Foundation · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Renal Cancer
• Renal Cell Carcinoma
• Renal Cell Cancer Metastatic

Timeline

• Start date: 2023-01-19
• Primary completion: 2030-01-01
• Completion: 2030-01-01
• First posted: 2022-04-13
• Last updated: 2025-06-06

Locations

27 sites across 1 country: Netherlands