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
|Condition or disease|
|Patients With Newly Diagnosed Small Renal Masses(<4cm)|
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.
|Study Type :||Observational|
|Estimated Enrollment :||170 participants|
|Official Title:||Role of Active Surveillance and Identification of Prognostic Factors for Progression in Early Stage Renal Cell Carcinoma|
|Study Start Date :||August 2004|
|Estimated Primary Completion Date :||December 2020|
|Estimated Study Completion Date :||January 2024|
- 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
- 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.
Biospecimen Retention: Samples With DNA
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01305330
|Contact: Laura Legere, BScNemail@example.com|
|Contact: Rehab Chahin, PhD||416-946-4501 ext firstname.lastname@example.org|
|Princess Margaret Hospital, University Health Network||Recruiting|
|Toronto, Ontario, Canada, M5G 2M9|
|Principal Investigator: Michael AS Jewett, MD, FRCSC|
|Principal Investigator:||Michael AS Jewett, MD, FRCSC||University Health Network, Princess Margaret Hospital|