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

PROspective Renal Cancer Cohort (PRO-RCC)

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05326620

Acronym

PRO-RCC

Enrollment

2000

Registered

2022-04-13

Start date

2023-01-19

Completion date

2030-01-31

Last updated

2025-06-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Renal Cancer, Renal Cell Cancer Metastatic, Renal Cell Carcinoma

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
survival	5 years	overall survival
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.

Secondary

Measure	Time frame	Description
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)

Countries

Netherlands

Contacts

Primary ContactHilin Yildirim, MD

h.yildirim@iknl.nl0031643202583

Outcome results