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

P

PROspective Renal Cancer Cohort Foundation

Status

Enrolling

Conditions

Renal Cell Cancer Metastatic
Renal Cancer
Renal Cell Carcinoma

Study type

Observational

Funder types

Other
Industry

Identifiers

NCT05326620
2021_218

Details and patient eligibility

About

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.

Full 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.

Enrollment

2,000 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No 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

Trial design

2,000 participants in 2 patient groups

localized RCC
Description:
all patients with localized RCC
metastatic RCC
Description:
all patients with metastatic RCC, synchronous or metachronous

Trial contacts and locations

28

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Central trial contact

Hilin Yildirim, MD

Data sourced from clinicaltrials.gov

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