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


N/A
18 Years
N/A
Open (Enrolling)
Both
Patients With Newly Diagnosed Small Renal Masses(<4cm)

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Trial Information

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


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.


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

Type of Study:

Observational

Study Design:

Observational Model: Case-Only, Time Perspective: Prospective

Outcome Measure:

Tumour progression:

Outcome Description:

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

Outcome Time Frame:

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

Safety Issue:

Yes

Principal Investigator

Michael A.S. Jewett, MD, FRCSC, FACS

Investigator Role:

Principal Investigator

Investigator Affiliation:

University Health Network, Princess Margaret Hospital

Authority:

Canada: Ethics Review Committee

Study ID:

SRM

NCT ID:

NCT01305330

Start Date:

August 2004

Completion Date:

Related Keywords:

  • Patients With Newly Diagnosed Small Renal Masses(<4cm)
  • small renal mass
  • active surveillance
  • kidney mass
  • kidney tumour

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