Active Surveillance of the Small Renal Mass

NCT ID: NCT02204800

Last Updated: 2021-03-01

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 4 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-12-31
• Study Completion Date: 2020-08-31

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.

Conditions

Small Renal Mass, Kidney Cancer

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Study Groups

Small clear cell renal tumors (Wild Type)

No specific chromatin remodeling gene (CRG) alteration

No interventions assigned to this group

Small clear cell renal tumors (Mutant)

Specific chromatin remodeling gene (CRG) alteration

No interventions assigned to this group

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Yale University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Brian Shuch, MD

Role: PRINCIPAL_INVESTIGATOR

Yale University

Locations

Yale New Haven Hospital Smilow Cancer Center

New Haven, Connecticut, United States

Countries

United States

Other Identifiers

Yale Department of Urology

Identifier Type: OTHER

Identifier Source: secondary_id

1312013110

Identifier Type: -

Identifier Source: org_study_id