Active Surveillance of the Small Renal Mass
| Status: | Recruiting |
|---|---|
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 5/27/2018 |
| Start Date: | December 2014 |
| End Date: | August 31, 2022 |
| Contact: | Brian Shuch, MD |
| Email: | brian.shuch@yale.edu |
| Phone: | 203-785-2815 |
Active Surveillance of the Small Renal Mass: An Integrated Biomarker Trial
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.
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.
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.
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.
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
We found this trial at
1
site
New Haven, Connecticut 06510
Principal Investigator: Brian Shuch, MD
Phone: 203-737-6332
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