Active Surveillance of the Small Renal Mass
Completed
Conditions studied: Small Renal Mass, Kidney Cancer
In brief
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.
Key facts
- Study ID
- NCT02204800
- Run by
- Yale University
- People needed
- 4
- Starts
- 2014-12-01
- Expected to finish
- 2020-08-31
- Last updated by the study team
- 2021-03-01
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Yale New Haven Hospital Smilow Cancer Center — New Haven, Connecticut, United States
Full record on ClinicalTrials.gov
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