The Natural History of Small Renal Masses

NCT01305330 | Completed

• 1 other identifier: SRM
• Study Type: observational
• Target: 137
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

small renal mass; active surveillance; kidney mass; kidney tumour

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Time to Tumour Progression

  4 times year 1, 2 times year 2 and 3, yearly thereafter

• Growth rate

  4 times year 1, 2 times year 2 and 3, yearly thereafter

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Primary care clinic

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Health Network, Toronto: lead
• The Kidney Foundation of Canada: collaborator
• Canadian Urologic Oncology Group: collaborator

Study Sites (1)

Princess Margaret Hospital, University Health Network

Toronto, Ontario, M5G 2M9, Canada

Location

Biospecimen

Retention: SAMPLES WITH DNA

Biopsy cores, nephrectomy tissue, and blood and urine will be collected

MeSH Terms

Conditions

Carcinoma, Renal Cell

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases

Study Officials

• Michael AS Jewett, MD, FRCSC

  University Health Network, Princess Margaret Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 18, 2011
• First Posted: February 28, 2011
• Study Start: August 1, 2004
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2019
• Last Updated: September 10, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)