Ignite Creation Date:
2025-12-25 @ 4:18 AM
Ignite Modification Date:
2026-01-13 @ 5:25 PM
Study NCT ID:
NCT05326620
Status:
RECRUITING
Last Update Posted:
2025-06-06
First Post:
2022-03-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
National PROspective Infrastructure for Renal Cell Carcinoma (PRO-RCC)
Sponsor:
PROspective Renal Cancer Cohort Foundation
Organization:
Study Overview
Official Title:
PROspective Renal Cancer Cohort (PRO-RCC)
Status:
RECRUITING
Status Verified Date:
2025-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PRO-RCC
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: