We'd like your feedback
Your feedback is important to us. It will help us improve the quality of the study information on this site. Please answer both questions.
Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.
Mr
Chris
Blick
karen.wilmott@royalberkshire.nhs.uk
Layla
Al-Bustani
karen.wilmott@royalberkshire.nhs.uk
Karen
Wilmott
karen.wilmott@royalberkshire.nhs.uk
Mr
Chris
Blick
christopher.blick@royalberkshire.nhs.uk
Malignant neoplasms of urinary tract
This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.
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.
Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.
The recruitment start and end dates are as follows:
Observational type: Validation of outcome measures;
You can take part if:
You may not be able to take part if:
o Renal tumors with a non-RCC histology (sarcomas, lymphomas, etc.). o Presence of metastatic disease at diagnosis Îż 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.
Below are the locations for where you can take part in the trial. Please note that not all sites may be open.
Mr
Chris
Blick
christopher.blick@royalberkshire.nhs.uk
Mr
Chris
Blick
karen.wilmott@royalberkshire.nhs.uk
Layla
Al-Bustani
karen.wilmott@royalberkshire.nhs.uk
Karen
Wilmott
karen.wilmott@royalberkshire.nhs.uk
The study is sponsored by European Association of Urology and funded by European Association of Urology .
Your feedback is important to us. It will help us improve the quality of the study information on this site. Please answer both questions.
Read full details
for Trial ID: CPMS 38918
You can print or share the study information with your GP/healthcare provider or contact the research team directly.
