European active surveillance of renal cell carcinoma study (E.A.S.E. RCC study)
- Conditions
- renal cell carcinoma10038364
- Registration Number
- NL-OMON47206
- Lead Sponsor
- CuraTrial SMO & Research
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 20
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 refusing active treatment.
o Signed Informed consent.
o Preparedness to comply with percutaneous tumor biopsy and a close follow-up protocol.
o Renal tumors with a non-RCC histology (sarcomas, lymphomas, etc.).
o Tumor related symptoms at presentation.
o Patients with known genetic diseases associated with RCC (e.g. Van Hippel Landau).
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.
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Primary endpoint is overall survival.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary endpoints are tumor growth rate, progression rate, cancer-specific<br /><br>survival, progression-free survival, identification of clinical and<br /><br>pathological variables and molecular and genetic markers that correlate with<br /><br>growth rate and progression.</p><br>