Global Renal Mass Study - A prospective International Study on Indications, Treatment Modalities and Outcomes 

During the past years we are witnessing an increased interest in Renal masses. Two main reasons are responsible for this: the increasing diagnostic incidence which leads to incidental discovery of small renal masses and the development and consolidation of partial nephrectomy and minimal invasive surgical treatments, the latter including the laparoscopic approach and ablation techniques.

However, there are some fundamental differences concerning indication for surgery, experience and technique used mainly based on institutional characteristics. Those factors may modulate outcomes. Moreover, specific patient and technique factors may influence treatment related morbidity. In this prospective study we aim to assess on a global basis the indications, treatment modality and outcomes of instrumental treatment for renal masses including (laparoscopic/robotic) radical or partial nephrectomy and (percutaneous/laparoscopic assisted) ablative treatments. Each centre participating in this project will include during a one-year period all the patients treated at their site, with the diagnostic of renal mass.

Download the Renal Mass protocol

Primary study objective:

To assess the current patterns of surgical or instrumental treatment and indications for RCC treatment and treatment outcomes in terms of objective and subjective improvement.

Secondary study objectives: 

1. To assess the peri-operative morbidity (30 days) by using the Clavien score.
2. To define risk factors for the development of peri-operative morbidity after instrumental treatment.
3. To assess quality of life related to the different treatment modalities.
4. To asses pathological characteristics of the renal masses

Eventually collection on long-term follow (5-10 years) up would be recommended to all participant centres. Long-term data can be used to correlate initial pathology and treatment modality with oncological outcome as well as to test the predictive ability of different staging systems (TNM / Risk systems)

• Inclusion of data on all consecutive patients treated during a one-year period.

• Study initiated from each site once the first patient is enrolled. Each centre will close its participation exactly one year after inclusion of the first patient.

• There is no minimum or maximum of number of sites participating in this study, however, all sites must receive prior approval of the CROES council.

• Subject to the approval of the CROES council, the lead investigator at study sites must be a member of the Endourological Society and in good standing. Subject to the approval of the CROES council, study sites may be proposed by the members from the Steering committee or on recommendation from a third party.

• Electronic database will be maintained at the central data collection site selected by the CROES council and shall be updated on a regular basis as determined by the CROES council. A manager, selected by the CROES council, at the central data collection site will maintain and coordinate the data collection.  

• Prior to approval of the site by the CROES council, for quality assurance, either an IRB approval or a letter from the principal investigator of the study site assuring the quality and ethical standards of data collection will be provided.

• The members of the study group will receive feedback on the data collected on a regular basis, as determined by the CROES council. 

• The data analysis shall be the responsibility of the Steering committee for the study group.

• The Steering committee shall be comprised of 6-8 international members and a chairman. A good balance among the different treatment specialists is desirable. Representatives of the CROES council may be joining during the Steering committee meetings. Representatives from the supporter of the study will join the Steering Committee.