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The Natural History of Small Renal Masses

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ClinicalTrials.gov Identifier: NCT01305330
Recruitment Status : Recruiting
First Posted : February 28, 2011
Last Update Posted : May 31, 2017
The Kidney Foundation of Canada
Canadian Urologic Oncology Group
Information provided by (Responsible Party):
University Health Network, Toronto

February 18, 2011
February 28, 2011
May 31, 2017
August 2004
December 2020   (Final data collection date for primary outcome measure)
Tumour progression: [ Time Frame: 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
Same as current
Complete list of historical versions of study NCT01305330 on ClinicalTrials.gov Archive Site
  • Time to Tumour Progression [ Time Frame: 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 [ Time Frame: 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.
Same as current
Not Provided
Not Provided
The Natural History of Small Renal Masses
Role of Active Surveillance and Identification of Prognostic Factors for Progression in Early Stage Renal Cell Carcinoma
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.


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.
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Biopsy cores, nephrectomy tissue, and blood and urine will be collected
Non-Probability Sample
Primary care clinic
Patients With Newly Diagnosed Small Renal Masses(<4cm)
Not Provided
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
January 2024
December 2020   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact: Laura Legere, BScN 416-946-2282 laura.legere@uhn.ca
Contact: Rehab Chahin, PhD 416-946-4501 ext 3180 rehab.chahin@uhn.ca
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Plan to Share IPD: No
University Health Network, Toronto
University Health Network, Toronto
  • The Kidney Foundation of Canada
  • Canadian Urologic Oncology Group
Principal Investigator: Michael AS Jewett, MD, FRCSC University Health Network, Princess Margaret Hospital
University Health Network, Toronto
May 2017