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Active Surveillance of the Small Renal Mass

  • Study HIC#:1312013110
  • Last Updated:04/02/2020

Primary Objectives/Endpoints:

  • Tumor growth rate in maximal dimension between CRG gene status, wild-type (M0) vs. mutant (M1) groups

Secondary Objectives/Endpoints:

  • To determine if established clear cell mRNA subtypes (A and B) are predictive of tumor growth rate or need for surgical intervention
  • To determine the association between CRG status surgical intervention (analysis by threshold and/or patient preference) between M0 and M1 groups To investigate if HIF2 or Ki-67 protein expression assessed by Automated Quantitative Analysis of immunohistochemistry are predictors of rapid tumor growth Comparison of Patient Anxiety Scores over time and correlation to tumor growth Determination of MRI imaging characteristics dynamic contrast enhancement and apparent diffusion coefficients are predictive of rapid tumor growth
  • Age18 years and older
  • GenderBoth
  • Start Date07/27/2014
  • End Date07/31/2021

Trial Purpose and Description

Active surveillance in kidney cancer involves closely observing the tumor with periodic imaging studies rather than immediately proceeding to an invasive treatment. This does not mean that the tumor is ignored or that future treatment is not necessary, rather it means the tumor does not require treatment at this time. On active surveillance, a tumor is closely monitored without treatment, however if the tumor changes and reaches a predefined threshold that your physician no longer considers safe, your physician will strongly encourage treatment.

Eligibility Criteria

Inclusion Criteria:

  • Age ≥ 18 years
  • Life expectancy >3 years (by physician estimate)
  • Measurable, solid renal neoplasm, 1.0 -2.7 cm in size and visible on ultrasound
  • Clear cell renal cell carcinoma histology
  • Renal tumor diagnosed within 6 months
  • Recent biopsy (<6 weeks) performed, if performed at an outside institution, there must be sufficient material for biomarker analysis
  • No evidence of vascular invasion or regional nodal/distant disease
  • Renal tumor that is able to be managed with upfront surgery
  • Adequate organ function (Hemoglobin > 9, Absolute neutrophil count (ANC) ≥ 1500/μL Platelets ≥ 100,000/μL, AST and ALT ≤3.0 upper limit of normal (ULN), total bilirubin ≤ ULN, eGFR ≥ 30
  • Good Performance status (ECOG ≤2)
  • Understanding and willingness to provide consent

Exclusion Criteria:

  • History of a hereditary renal cancer syndrome
  • Tumor >2.7 cm, stages T1b-T4
  • Life expectancy <3 years
  • Presence of an active, untreated, metastatic non-renal malignancy
  • Uncontrolled medical illness including infections, hypertension, arrhythmias, heart failure, or myocardial infarction within 6 months that would predispose to immediate surgical therapy
  • Medical contraindication to upfront surgical management of renal mass
  • History of bleeding diathesis or recent bleeding episode that would prevent surgical resection
  • Unwillingness to undergo monitoring and imaging studies

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