No registrations found.
Source
Brief title
Health condition
Renal Cell Carcinoma
Sponsors and support
Intervention
No registrations found.
Outcome measures
Primary outcome
Overall survival
Secondary outcome
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.
Background summary
A total of 400 patients with small, incidentally detected, histologically confirmed Renal Cell Carcinoma (RCC) will be included and data related to the oncological outcomes of an active surveillance approach will be collected. 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.
Study objective
The objective of this study is to define the natural history of small, incidentally detected, histologically confirmed RCCs and the oncological outcomes of an active surveillance approach for this category of renal tumors in a prospective, multi-national clinical registry study.
Study design
N/A
Intervention
Active surveillance approach
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
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
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
NTR-new | NL7485 |
Other | EAU Research Foundation : EAU-RF 2015-01 |