EASE RCC study
- Conditions
- Renal Cell Carcinoma
- Registration Number
- NL-OMON25726
- Lead Sponsor
- niversity of Eastern Piedmont Department of Translational Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 400
oMales or females, age = 18 years.
oIncidental diagnosis at imaging (ultrasonography, CT, MRI) of a solid renal mass < 4 cm in maximum diameter (pT1a).
oHistologically confirmed RCC by percutaneous needle biopsy at diagnosis. All RCC subtypes are eligible for the study.
oPatients unfit for active treatment due to advanced age, or co-morbidity, or choosing to avoid active treatment.
oSigned Informed consent.
oPreparedness to comply with percutaneous tumor biopsy and a close follow-up protocol
oRenal tumors with a non-RCC histology (sarcomas, lymphomas, etc.).
oPresence of metastatic disease at diagnosis
oTumor related symptoms at presentation.
oPatients with known genetic diseases associated with RCC (VHL, BHD, HLRCC, etc.).
oPatients unsuitable for biopsy due to need for concomitant anticoagulation or anti-platelet drug use which cannot be transiently discontinued.
oPatients unsuitable for biopsy due to tumor location or small tumor size.
oPatients with concurrent systemic treatment for another cancer.
oPatients with estimated life expectancy < 1 year.
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Overall survival
- Secondary Outcome Measures
Name Time Method oTumor growth <br>oProgression rate<br>oCancer-specific survival <br>oProgression-free survival <br>oComparison of overall survival in this study population to the overall survival of the general population with similar age and co-morbidities and without RCC <br>oIdentification of clinical and pathological variables that correlate with growth rate and progression of small RCCs for each of the RCC subtypes. <br>oIdentification of molecular and genetic markers that correlate with growth rate and progression of small RCCs.<br>