European Active Surveillance of Renal Cell Carcinoma study
Research type
Research Study
Full title
European Active Surveillance of Renal Cell Carcinoma study
IRAS ID
219948
Contact name
Chris Blick
Contact email
Sponsor organisation
University of Eastern Piedmont, Department of Translational Medicine
Duration of Study in the UK
6 years, 5 months, 30 days
Research summary
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.REC name
South Central - Berkshire B Research Ethics Committee
REC reference
18/SC/0326
Date of REC Opinion
2 Oct 2018
REC opinion
Further Information Favourable Opinion