Active Surveillance of the Small Renal Mass

Small Renal Mass, Kidney Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02204800
• Other study ID #: 1312013110
• Secondary ID: Yale Department
• Status: Completed
• Start date: December 2014
• Est. completion date: August 31, 2020

Study information

• Verified date: February 2021
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4
• Est. completion date: August 31, 2020
• Est. primary completion date: August 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Kidney Neoplasms
• Small Renal Mass, Kidney Cancer

Locations

Country	Name	City	State
United States	Yale New Haven Hospital Smilow Cancer Center	New Haven	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
Yale University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tumor growth rate	Tumor growth rate is being measured in centimeters/year	36 months