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The Natural History of Small Renal Masses

This study is currently recruiting participants.
Verified May 2017 by University Health Network, Toronto
Sponsor:
ClinicalTrials.gov Identifier:
NCT01305330
First Posted: February 28, 2011
Last Update Posted: May 31, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborators:
The Kidney Foundation of Canada
Canadian Urologic Oncology Group
Information provided by (Responsible Party):
University Health Network, Toronto
  Purpose
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.

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

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Role of Active Surveillance and Identification of Prognostic Factors for Progression in Early Stage Renal Cell Carcinoma

Resource links provided by NLM:


Further study details as provided by University Health Network, Toronto:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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
Biopsy cores, nephrectomy tissue, and blood and urine will be collected

Estimated Enrollment: 170
Study Start Date: August 2004
Estimated Study Completion Date: January 2024
Estimated Primary Completion Date: December 2020 (Final data collection date for primary outcome measure)
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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Primary care clinic
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
  Contacts and Locations
Information from the National Library of Medicine

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


Contacts
Contact: Laura Legere, BScN 416-946-2282 laura.legere@uhn.ca
Contact: Rehab Chahin, PhD 416-946-4501 ext 3180 rehab.chahin@uhn.ca

Locations
Canada, Ontario
Princess Margaret Hospital, University Health Network Recruiting
Toronto, Ontario, Canada, M5G 2M9
Principal Investigator: Michael AS Jewett, MD, FRCSC         
Sponsors and Collaborators
University Health Network, Toronto
The Kidney Foundation of Canada
Canadian Urologic Oncology Group
Investigators
Principal Investigator: Michael AS Jewett, MD, FRCSC University Health Network, Princess Margaret Hospital
  More Information

Responsible Party: University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT01305330     History of Changes
Other Study ID Numbers: SRM
First Submitted: February 18, 2011
First Posted: February 28, 2011
Last Update Posted: May 31, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University Health Network, Toronto:
small renal mass
active surveillance
kidney mass
kidney tumour