Role of Active Surveillance and Identification of Prognostic Factors for Progression in Early Stage Renal Cell Carcinoma
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
Tumour progression:
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
4 times year 1, 2 times year 2 and 3, yearly thereafter
Yes
Michael A.S. Jewett, MD, FRCSC, FACS
Principal Investigator
University Health Network, Princess Margaret Hospital
Canada: Ethics Review Committee
SRM
NCT01305330
August 2004
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