The Natural History of Small Renal Masses

NCT ID: NCT01305330

Last Updated: 2020-09-10

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 137 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2004-08-31
• Study Completion Date: 2019-12-31

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.

Conditions

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

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Kidney Foundation of Canada

OTHER

Sponsor Role: collaborator

Canadian Urologic Oncology Group

OTHER

Sponsor Role: collaborator

University Health Network, Toronto

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michael AS Jewett, MD, FRCSC

Role: PRINCIPAL_INVESTIGATOR

University Health Network, Princess Margaret Hospital

Locations

Princess Margaret Hospital, University Health Network

Toronto, Ontario, Canada

Countries

Canada

Other Identifiers

SRM

Identifier Type: -

Identifier Source: org_study_id