European active surveillance of renal cell carcinoma study (E.A.S.E. RCC study)

Active surveillance can be considered a reasonable strategy for elderly
patients with small renal tumors or patients with significant comorbidities who
are not good surgical candidates. However, most available studies on active
surveillance include small renal tumors that were not histologically confirmed
as RCCs, including a proportion of benign tumors. Furthermore, follow-up
protocol and indications to delayed intervention during active surveillance
have not been generally standardized. There is a clear need of information on
the growth rate and oncological outcomes of histologically confirmed RCCs by
percutaneous biopsy at diagnosis and on the results of a standardized protocol
of active surveillance of small RCCs.
Furthermore, if the measurement of tumor growth rate seems to be helpful for
initial conservative management of patients with incidentally diagnosed small
renal tumors, it is necessary to identify reliable genetic or molecular serum,
urine or tissue markers that can differentiate small renal tumors with
different inherent aggressiveness and metastatic potential at diagnosis,
thereby enabling the urologist to choose the most suitable conservative or
active, individualized management approach for each patient.

The primary objective of this study is to assess overall survival of patients
who are diagnosed with incidental, histologically (biopsy) confirmed, <4 cm RCC
and are managed conservatively with active surveillance.

The secondary objectives are:
o to assess growth rate and progression rate of newly diagnosed, incidental,
histologically (biopsy) confirmed, <4 cm RCCs that are followed conservatively
with serial imaging.
o to assess cancer-specific and progression-free survival of patients who are
diagnosed with such tumors and are managed conservatively with active
surveillance.
o to demonstrate that overall survival in this study population is not
significantly different compared to the overall survival of the general
population with similar age and co-morbidities and without RCC.
o to identify clinical and pathological prognostic factors of fast growth rate
and progression for small RCCs.
o to evaluate the correlation of serum and/or urine molecular and genetic
markers with growth rate and progression of small RCCs.
o to evaluate the correlation of molecular and genetic features on needle
biopsies of small RCCs with growth rate and progression.

This is a prospective, multi-national clinical registry study conducted in
European countries by hospital based urologists. A total of 400 patients with
small, incidentally detected, histologically confirmed RCCs will be included
and data related to the oncological outcomes of an active surveillance approach
will be collected.

The burden and risks associated with participation in the study is considered
minimal and acceptable. The number of visits is considered to be equal to
standard practice. Laboratory and radiological evaluations are not considered
extra and are performed according to standard practice or at the investigators
discretion for monitoring possible progression of disease.
The only extra procedures are blood collection for future analyses and
questionnaires completion.
By being enrolled in an active surveillance protocol, surgical treatment with
the related anesthesiological and surgical risks may be avoided. Also worsening
of renal function due to removal of the kidney or part of it may be avoided.
The risk of spreading of tumor cells outside the kidney while in surveillance
is rare (1-2%) when delayed intervention is performed if the tumor grows or
tumor-related symptoms develop.
Information learned from this study may benefit other patients who have a
similar disease in the future.