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

Uncategorized

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

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

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.

Study Type: Observational

Clinical Trials Identifier NCT 8-digits: NCT01305330

Sponsor: University Health Network, Toronto

Primary Outcome Measures:

  • Measure: Tumour progression:
  • Time Frame: 4 times year 1, 2 times year 2 and 3, yearly thereafter
  • Safety Issue:

Secondary Outcome Measures:

  • Measure: Time to Tumour Progression
  • Time Frame: 4 times year 1, 2 times year 2 and 3, yearly thereafter
  • Safety Issue:
  • Measure: Growth rate
  • Time Frame: 4 times year 1, 2 times year 2 and 3, yearly thereafter
  • Safety Issue:

Estimated Enrollment: 170

Study Start Date: August 2004

Notice: Undefined property: stdClass::$phase in /home/urotoday/public_html/administrator/components/com_clinicaltrials/ClinicalTrials/Trial.php on line 192

Phase: Notice: Undefined property: stdClass::$phase in /home/urotoday/public_html/administrator/components/com_clinicaltrials/ClinicalTrials/Trial.php on line 192

Eligibility:

  • Age: minimum 18 Years maximum N/A
  • Gender: All

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

Contact:

  • Laura Legere, BScN
  • 416-946-2282

Location:

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

View trial on ClinicalTrials.gov

X