Active Surveillance of the Small Renal Mass

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.

Study Overview

• Status: Completed
• Conditions: Small Renal Mass, Kidney Cancer

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.

• Study Type: Observational
• Enrollment (Actual): 4

Contacts and Locations

Study Locations

• United States
  • Connecticut
    • New Haven, Connecticut, United States, 06510
      • Yale New Haven Hospital Smilow Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Small clear cell renal tumors (Wild Type); No specific chromatin remodeling gene (CRG) alteration
Small clear cell renal tumors (Mutant); Specific chromatin remodeling gene (CRG) alteration

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tumor growth rate	Tumor growth rate is being measured in centimeters/year	36 months

Collaborators and Investigators

• Sponsor: Yale University
• Investigators: Principal Investigator: Brian Shuch, MD, Yale University

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 1, 2014
• Primary Completion (ACTUAL): August 31, 2020
• Study Completion (ACTUAL): August 31, 2020

Study Registration Dates

• First Submitted: July 28, 2014
• First Submitted That Met QC Criteria: July 29, 2014
• First Posted (ESTIMATE): July 30, 2014

Study Record Updates

• Last Update Posted (ACTUAL): March 1, 2021
• Last Update Submitted That Met QC Criteria: February 26, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: Tumor growth rate in maximal dimension, biomarker assessment based on driver gene alterations (specifically CRG)
• Additional Relevant MeSH Terms: Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Kidney Diseases; Urologic Diseases; Kidney Neoplasms
• Other Study ID Numbers: 1312013110; Yale Department of Urology (OTHER: Yale Department of Urology)