Active Surveillance of the Small Renal Mass: An Integrated Biomarker Trial

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Active Surveillance of the Small Renal Mass: An Integrated Biomarker Trial

Condition: Small Renal Mass, Kidney Cancer

Purpose: 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.

Study Type: Observational

Clinical Trials Identifier NCT 8-digits: NCT02204800

Sponsor: Yale University

Primary Outcome Measures:

  • Measure: Tumor growth rate
  • Time Frame: 36 months
  • Safety Issue:

Estimated Enrollment: 48

Study Start Date: December 2014

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Eligibility:

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

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

Contact:

  • Brian Shuch, MD
  • 203-785-2815

Location:

  • Yale New Haven Hospital Smilow Cancer Center
  • New Haven Connecticut 06510 United States

View trial on ClinicalTrials.gov

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