Patients With Newly Diagnosed Small Renal Masses(<4cm)
Conditions
Keywords
small renal mass, active surveillance, kidney mass, kidney tumour
Brief summary
There is a rising incidence of incidentally detected small renal tumours due to improved imaging techniques. Traditionally, patients diagnosed with these small renal masses undergo surgery and therefore there is limited data about the natural history of these tumours. Several small series have reported that most of these small masses grow slowly and might not require early intervention and that only some masses grow rapidly requiring immediate surgery. Presently, the investigators have not been able to identify prospectively which masses are going to grow slowly. The investigators plan to use computed tomography (CT) and Magnetic Resonance Imaging (MRI) parameters, microsatellite analysis and tissue analysis to determine which masses will behave more aggressively. Additionally, the observations on the natural history of small renal masses need to be validated with a multicentric and systematically followed cohort.
Detailed description
Hypothesis Since most renal cell carcinomas (RCC's) that are now detected by imaging as small renal masses, grow slowly and remain asymptomatic for years, we hypothesize that: * Small RCC's that are destined to metastasize do so early or after they reach a larger size * Delayed surgical treatment of asymptomatic, incidentally detected, small RCC's WILL NOT have a significant impact on overall survival * The majority of small RCC's MAY NOT need to be treated. * RCC's that are destined to progress can be identified by abnormal perfusion patterns on imaging and by their cellular and genomic characteristics on needle biopsy.
Interventions
None listed
Sponsors
The Kidney Foundation of Canada
Canadian Urologic Oncology Group
University Health Network, Toronto
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Asymptomatic T1a (\< 4.0 cm) renal mass and unfit for surgery due to advanced age or co-morbidity, OR * Asymptomatic T1a (\< 4.0 cm) and refusal of surgery * No evidence of metastatic disease (N0M0) * Preparedness to comply with a close follow-up protocol * Informed consent
Exclusion criteria
* Life expectancy \< 2 years * Already being followed for a small renal mass for more than 12 months * Concurrent systemic therapy for other malignancies * Known hereditary renal cancer syndromes
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Tumour progression: | 4 times year 1, 2 times year 2 and 3, yearly thereafter | i) calculated tumour volume doubles (100% increase) within any one-year period, and/or ii) the maximum tumour diameter reaches 4 cm., and/or iii) patients develop symptoms considered to be possibly due to their renal tumour and/or iv) patients develop metastases |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to Tumour Progression | 4 times year 1, 2 times year 2 and 3, yearly thereafter | Time to tumour progression will be measured from the date of diagnosis to the date of progression or, if progression has not occurred, until the date of last follow-up. |
| Growth rate | 4 times year 1, 2 times year 2 and 3, yearly thereafter | Defined by volume (cm3 ) measured over time (years). Tumour bi-dimensional diameter will be recorded and reported to allow comparison with the literature to date. Tumour volume will be calculated from follow-up images using the formula for ellipsoid volume: 0.5326 x X x Y x Z. |
Countries
Canada
Outcome results
None listed