Renal Cell Carcinoma
Conditions
Interventions
Active surveillance approach
Sponsors
University of Eastern Piedmont Department of Translational Medicine
Eligibility
Inclusion criteria
Inclusion criteria: o Males or females, age = 18 years. o Incidental diagnosis at imaging (ultrasonography, CT, MRI) of a solid renal mass < 4 cm in maximum diameter (pT1a). o Histologically confirmed RCC by percutaneous needle biopsy at diagnosis. All RCC subtypes are eligible for the study. o Patients unfit for active treatment due to advanced age, or co-morbidity, or choosing to avoid active treatment. o Signed Informed consent. o Preparedness to comply with percutaneous tumor biopsy and a close follow-up protocol
Exclusion criteria
Exclusion criteria: o Renal tumors with a non-RCC histology (sarcomas, lymphomas, etc.). o Presence of metastatic disease at diagnosis o Tumor related symptoms at presentation. o Patients with known genetic diseases associated with RCC (VHL, BHD, HLRCC, etc.). o Patients unsuitable for biopsy due to need for concomitant anticoagulation or anti-platelet drug use which cannot be transiently discontinued. o Patients unsuitable for biopsy due to tumor location or small tumor size. o Patients with concurrent systemic treatment for another cancer. o Patients with estimated life expectancy < 1 year.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall survival | — |
Secondary
| Measure | Time frame |
|---|---|
| o Tumor growth o Progression rate o Cancer-specific survival o Progression-free survival o Comparison of overall survival in this study population to the overall survival of the general population with similar age and co-morbidities and without RCC o Identification of clinical and pathological variables that correlate with growth rate and progression of small RCCs for each of the RCC subtypes. o Identification of molecular and genetic markers that correlate with growth rate and progression of small RCCs. | — |
Contacts
Public ContactChristien Caris
EAU Research Foundation
Outcome results
None listed