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.

Study Overview

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

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 Type: Observational
• Enrollment (Actual): 137

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5G 2M9
      • Princess Margaret Hospital, University Health Network

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Primary care clinic

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to Tumour Progression	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.	4 times year 1, 2 times year 2 and 3, yearly thereafter
Growth rate	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.	4 times year 1, 2 times year 2 and 3, yearly thereafter

Collaborators and Investigators

• Sponsor: University Health Network, Toronto
• Collaborators: The Kidney Foundation of Canada; Canadian Urologic Oncology Group
• Investigators: Principal Investigator: Michael AS Jewett, MD, FRCSC, University Health Network, Princess Margaret Hospital

Study record dates

Study Major Dates

• Study Start: August 1, 2004
• Primary Completion (Actual): December 1, 2019
• Study Completion (Actual): December 1, 2019

Study Registration Dates

• First Submitted: February 18, 2011
• First Submitted That Met QC Criteria: February 25, 2011
• First Posted (Estimate): February 28, 2011

Study Record Updates

• Last Update Posted (Actual): September 10, 2020
• Last Update Submitted That Met QC Criteria: September 8, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Keywords: active surveillance; small renal mass; kidney tumour; kidney mass
• Other Study ID Numbers: SRM

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No