Kidney Cancer Clinical Trial
Active Surveillance of the Small Renal Mass
Summary
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.
Full Description
While some patients with small kidney tumors may require eventual treatment, most do not. Therefore, the American Urologic Association considers active surveillance an acceptable treatment strategy. This protocol is a prospective study of active surveillance for small clear cell kidney tumors (the most common type of kidney tumor) and is designed to identify if there are predictive markers that may help identify which patients are unlikely to require surgical treatment. Predictive markers are measurable characteristics that may predict the future behavior of a tumor. There are currently no available predictive markers that can help identify which tumors are not destined to require treatment. Such a marker may be useful to increase the use of active surveillance by informing patients with small renal tumors that immediate treatment may be considered overtreatment.
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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There is 1 Location for this study
New Haven Connecticut, 06510, United States
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