The Natural History of Small Renal Masses
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.
Patients With Newly Diagnosed Small Renal Masses(<4cm)
|Study Design:||Observational Model: Case-Only
Time Perspective: Prospective
|Official Title:||Role of Active Surveillance and Identification of Prognostic Factors for Progression in Early Stage Renal Cell Carcinoma|
- Tumour progression: [ Time Frame: 4 times year 1, 2 times year 2 and 3, yearly thereafter ] [ Designated as safety issue: Yes ]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
- Time to Tumour Progression [ Time Frame: 4 times year 1, 2 times year 2 and 3, yearly thereafter ] [ Designated as safety issue: No ]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 [ Time Frame: 4 times year 1, 2 times year 2 and 3, yearly thereafter ] [ Designated as safety issue: No ]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.
Biospecimen Retention: Samples With DNA
Biopsy cores, nephrectomy tissue, and blood and urine will be collected
|Study Start Date:||August 2004|
|Estimated Primary Completion Date:||December 2015 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01305330
|Contact: Laura Legere, BScNfirstname.lastname@example.org|
|Contact: Rehab Chahin, PhD||416-946-4501 ext email@example.com|
|Princess Margaret Hospital, University Health Network||Recruiting|
|Toronto, Ontario, Canada, M5G 2M9|
|Principal Investigator: Michael A.S. Jewett, MD, FRCSC, FACS|
|Principal Investigator:||Michael A.S. Jewett, MD, FRCSC, FACS||University Health Network, Princess Margaret Hospital|