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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05326620
Other study ID # 2021_218
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date January 19, 2023
Est. completion date January 2030

Study information

Verified date January 2024
Source PROspective Renal Cancer Cohort Foundation
Contact Hilin Yildirim, MD
Phone 0031643202583
Email h.yildirim@iknl.nl
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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.


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), symptom monitoring with optional ecological momentary assessment (EMA) of pain and fatigue, and optional return to work- and/or nutrition 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 2000
Est. completion date January 2030
Est. primary completion date January 2030
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Locations

Country Name City State
Netherlands Jeroen Bosch Ziekenhuis 's-Hertogenbosch
Netherlands Meander Medisch Centrum Amersfoort
Netherlands Amsterdam UMC locatie VUMC Amsterdam Noord Holland
Netherlands Amphia Ziekenhuis Breda
Netherlands Deventer Ziekenhuis Deventer
Netherlands Treant Emmen
Netherlands UMCG Groningen
Netherlands Maastricht UMC Maastricht
Netherlands St Antonius Ziekenhuis Nieuwegein
Netherlands Bravis ziekenhuis Roosendaal

Sponsors (5)

Lead Sponsor Collaborator
PROspective Renal Cancer Cohort Foundation Bristol-Myers Squibb, Comprehensive Cancer Centre The Netherlands, Ipsen, Merck Sharp & Dohme LLC

Country where clinical trial is conducted

Netherlands, 

Outcome

Type Measure Description Time frame Safety issue
Primary survival overall survival 5 years
Primary progression local or distant recurrence 5 years
Primary patient reported outcome measures (PROMS) measured with the EORTC QLQ-C30 questionnaire, every three months in the first year, then yearly up to five years. 5 years
Secondary Patient reported outcomes of adverse events 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) 2 years
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