National PROspective infrastructure for Renal Cell Carcinoma (2024)

Download: PDF | XML

Primary outcome

This efficient and unique infrastructure for RCC research creates a facility,

that will yield detailed insights in RCC disease aspects and treatment in the

Netherlands and enable improved patient accrual in clinical trials. Ultimately,

this will lead to an introduction of improved new treatment options in daily

clinical practice. Furthermore, the collected data on HRQoL, symptoms and

clinical management from diagnosis to death will result in robust *real-world*

patient data. Data from patients who undergo registered and experimental

therapies can be studied to answer relevant questions on relapse and

progression to invasive or metastatic disease, and on optimal (sequencing of)

treatment regimens and HRQoL as part of the decision making.

Secondary outcome

Background summary

Survival after a renal cell cancer (RCC) diagnosis strongly depends on local
tumor extent, lymph node involvement and the presence of distant metastases.
However, there remains high inter-patient variability regarding clinical
treatment outcome and there is hardly knowledge about impact on health-related
quality of life (HRQoL). The clinical outcome is likely to be influenced by a
combination of biochemical factors, histopathological features, genomic
profile, environmental factors and other clinical factors, independent from
tumor stage. However, it is still unclear which, how, and to what extent these
factors influence tumor recurrence and mortality in both early stage (I-Ill)
RCC and late stage (IV) mRCC in the general population.
As a result of rapid technical developments, a range of new minimally invasive
treatment options for RCC have entered the clinic. These interventions aim for
optimal local control with less damage to surrounding tissue, faster recovery
and less side effects. However, most of these interventions have not been
thoroughly evaluated in trials yet. Besides, many new medicines for the
treatment of RCC have recently become available. The impact of these systemic
treatments on HRQoL and symptoms in the general population during active
treatment and thereafter remains unclear. Therefore it is highly desirable to
validate results from clinical trials on treatment outcomes in real-world data.
Unfortunately, the current documentation of patients treated in general
practice is insufficient to provide comparable patient cohorts in terms of
prognostic characteristics, treatment parameters and patient-reported outcome
measures (PROMs). Also, there is an increased availability of molecular markers
with potential prognostic and/or predictive value. Validation of such markers
requires large numbers of patients, far more than the number of patients
participating in clinical trials.
Altogether, a prospective observational cohort combining PROMS and clinical
data provides the opportunity to fill these gaps. Our cohort will result in a
dataset that reliably represents the real-world situation of both localized and
metastatic RCC patients. This data will be highly informative for guiding
patients and health care professionals in the choice of treatment and will
improve the communication between patient and health care professional.
Moreover, this project will allow the design and execution of Trials within a
Cohort, the so-called TWICs or cohort multiple randomized controlled trials
(cmRCT). So, the existing infrastructure of the cohort will improve
possibilities for research among RCC patients.

Study objective

To set up a prospective, nationwide infrastructure that identifies and follows
patients diagnosed with RCC and mRCC over time. This infrastructure will:
• evaluate oncological and functional outcomes for patients diagnosed with RCC;
• evaluate the impact of RCC treatment on the following PROMS: HRQoL, symptoms,
work ability, nutrition;
• evaluate patient-experienced quality of care measures (PREMS);
• inform on the landscape of RCC in the Netherlands and evolving changes in
treatment;
• validate the (cost- )efficacy and safety of novel diagnostic and therapeutic
approaches in a real-world patient population; • facilitate selection of
eligible patients for future intervention studies, thereby improving accrual;
• yield historical and concurrent control groups fur future single arm
intervention studies;

Study design

All patients diagnosed with histologically proven RCC are eligible for PRO-RCC.
The infrastructure is embedded in the logistic framework of PROFILES and the
Netherlands Cancer Registry (NCR). PROMS will be collected longitudinally
through online questionnaires. Clinical data will be collected in a uniform
manner by trained independent data managers of the NCR.

Study burden and risks

n/a

Inclusion criteria

Exclusion criteria

Approved WMO

Date :

21-01-2022

Application type :

First submission

Review commission :

Approved WMO

Date :

25-05-2023

Application type :

Amendment

Review commission :

Approved WMO

Date :

01-09-2023

Application type :

Amendment

Review commission :

Approved WMO

Date :

01-11-2023

Application type :

Amendment

Review commission :

Approved WMO

Date :

13-06-2024

Application type :

Amendment

Review commission :