PROspective Renal Cancer Cohort (PRO-RCC)
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Renal Cancer
- Sponsor
- PROspective Renal Cancer Cohort Foundation
- Enrollment
- 2000
- Locations
- 26
- Primary Endpoint
- progression
- Status
- Recruiting
- Last Updated
- 11 months ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •newly diagnosed patients with RCC or synchronous metastatic RCC
- •metachronous metastasized RCC
- •age \>18 years
- •capable of understanding Dutch language
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
progression
Time Frame: 5 years
local or distant recurrence
patient reported outcome measures (PROMS)
Time Frame: 5 years
measured with the EORTC QLQ-C30 questionnaire, every three months in the first year, then yearly up to five years.
survival
Time Frame: 5 years
overall survival
Secondary Outcomes
- Patient reported outcomes of adverse events(2 years)