Health TrialsbyHealthPanel

National PROspective Infrastructure for Renal Cell Carcinoma (PRO-RCC)

ConditionsRenal CancerRenal Cell CarcinomaRenal Cell Cancer Metastatic
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorPROspective Renal Cancer Cohort Foundation

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

newly diagnosed patients with RCC or synchronous metastatic RCC

metachronous metastasized RCC

age >18 years

capable of understanding Dutch language

Disqualifiers

n/a

Trial population

all patients with newly diagnosed (m)RCC can be included, or with synchronous metastasized RCC

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

2,000 Participants
are grouped into 2 trial groups
Group A: localized RCC
Group B: metastatic RCC

Trial outcomes

Primary outcomes

1

survival

overall survival

Time frame
5 years
2

progression

local or distant recurrence

Time frame
5 years
3

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.

Time frame
5 years

Secondary outcomes

1

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)

Time frame
2 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

PROspective Renal Cancer Cohort Foundation

Lead sponsor

Comprehensive Cancer Centre The Netherlands

Collaborator

Merck Sharp & Dohme LLC

Collaborator

Bristol-Myers Squibb

Collaborator

Ipsen

Collaborator

Pfizer

Collaborator

Source ClinicalTrials.gov
Apply now