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Active Surveillance of the Small Renal Mass

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02204800
Recruitment Status : Completed
First Posted : July 30, 2014
Last Update Posted : March 1, 2021
Sponsor:
Information provided by (Responsible Party):
Yale University

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.

Condition or disease
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.

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Study Type : Observational
Actual Enrollment : 4 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Active Surveillance of the Small Renal Mass: An Integrated Biomarker Trial
Actual Study Start Date : December 2014
Actual Primary Completion Date : August 31, 2020
Actual Study Completion Date : August 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Cancer

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



Primary Outcome Measures :
  1. Tumor growth rate [ Time Frame: 36 months ]
    Tumor growth rate is being measured in centimeters/year



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02204800


Locations
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United States, Connecticut
Yale New Haven Hospital Smilow Cancer Center
New Haven, Connecticut, United States, 06510
Sponsors and Collaborators
Yale University
Investigators
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Principal Investigator: Brian Shuch, MD Yale University
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Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT02204800    
Other Study ID Numbers: 1312013110
Yale Department of Urology ( Other Identifier: Yale Department of Urology )
First Posted: July 30, 2014    Key Record Dates
Last Update Posted: March 1, 2021
Last Verified: February 2021
Keywords provided by Yale University:
Tumor growth rate in maximal dimension, biomarker assessment based on driver gene alterations (specifically CRG)
Additional relevant MeSH terms:
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Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Kidney Diseases
Urologic Diseases