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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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 AS Jewett, MD, FRCSC|
|Principal Investigator:||Michael AS Jewett, MD, FRCSC||University Health Network, Princess Margaret Hospital|