Clinical trial NCT02204800: Active Surveillance of the Small Renal Mass
Official title: Active Surveillance of the Small Renal Mass: An Integrated Biomarker Trial
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Small Renal Mass, Kidney Cancer
Keywords: Tumor growth rate in maximal dimension, biomarker assessment based on driver gene alterations (specifically CRG)
Lead sponsor: Yale University
Sponsor class: OTHER
First posted: 2014-07-30
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: This is a trial of active surveillance in patients with a solitary, small (1.0-2.7 cm) renal mass.

Brief 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.

Detailed 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

Primary outcomes:
measure: Tumor growth rate
timeFrame: 36 months
Secondary outcomes:
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale New Haven Hospital Smilow Cancer Center
state: Connecticut
Study officials:
affiliation: Yale University
name: Brian Shuch, MD
role: PRINCIPAL_INVESTIGATOR
References: