The Natural History of Small Renal Masses

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2013 by University Health Network, Toronto
Sponsor:
Collaborators:
The Kidney Foundation of Canada
Canadian Urologic Oncology Group
Information provided by (Responsible Party):
University Health Network, Toronto
ClinicalTrials.gov Identifier:
NCT01305330
First received: February 18, 2011
Last updated: January 15, 2013
Last verified: January 2013

February 18, 2011
January 15, 2013
August 2004
December 2015   (final data collection date for primary outcome measure)
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
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 ] [ 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.
Same as current
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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.

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.
Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

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
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
170
Not Provided
December 2015   (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
Both
18 Years and older
No
Contact: Laura Legere, BScN 416-946-2282 laura.legere@uhn.ca
Contact: Rehab Chahin, PhD 416-946-4501 ext 3180 rehab.chahin@uhn.ca
Canada
 
NCT01305330
SRM
No
University Health Network, Toronto
University Health Network, Toronto
  • The Kidney Foundation of Canada
  • Canadian Urologic Oncology Group
Principal Investigator: Michael A.S. Jewett, MD, FRCSC, FACS University Health Network, Princess Margaret Hospital
University Health Network, Toronto
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP