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NCT Number: NCT01305330

The Natural History of Small Renal Masses

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.

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Key information

Conditions

Patients With Newly Diagnosed Small Renal Masses(<4cm) Adenocarcinoma Carcinoma Carcinoma, Renal Cell Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Kidney Neoplasms Male Urogenital Diseases Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Princess Margaret Hospital, University Health Network

Toronto, Ontario, M5G 2M9, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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 outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

University Health Network, Toronto

Other

Collaborators

  • Canadian Urologic Oncology Group
  • The Kidney Foundation of Canada

Registry information

Official study title

Role of Active Surveillance and Identification of Prognostic Factors for Progression in Early Stage Renal Cell Carcinoma

Important dates

Study start
2004
Primary completion
2019
Study completion
2019
First posted
Feb 28, 2011
Registry last updated
Sep 10, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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