The Natural History of Small Renal Masses

Completed

• Conditions: Patients With Newly Diagnosed Small Renal Masses(<4cm)

• Registration Number: NCT01305330
• Lead Sponsor: University Health Network, Toronto

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2004-08
• Study First Submitted: 2011-02-18
• Study First Submitted QC: 2011-02-25
• Study First Posted: 2011-02-28
• Primary Completion: 2019-12
• Study Completion: 2019-12
• Status Verified: 2020-09
• Last Update Submitted: 2020-09-08
• Last Update Posted: 2020-09-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 137

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Tumour progression:	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

Secondary Outcome Measures

Name	Time	Method
Time to Tumour Progression	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	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.

Trial Locations

Locations (1)

Princess Margaret Hospital, University Health Network; 🇨🇦 Toronto, Ontario, Canada