National PROspective infrastructure for Renal Cell Carcinoma

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.

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;

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.

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