Ablation of Renal Masses Outcomes Registry (ARMOR): Ablation Procedure and Quality of Life Assessment

Active, not recruiting

Interventions: Behavioral: (EORTC QLQ-C30) questionnaire
Behavioral: EuroQol EQ-5D 7-item questionnaire

Brief Summary: The purpose of this study is to better understand how effective ablation is for destroying tumor cells in the kidney and whether quality of life is improved for patients. Participation in ARMOR may involve retrospective data collection only, combined retrospective and prospective data collection, or prospective data collection

Recruitment & Eligibility

Inclusion Criteria

Retrospective enrollment:

Patients having undergone percutaneous, open or laparoscopic energy ablation of a renal mass.

Prospective enrollment:

Patients scheduled to undergo, rather than having undergone, percutaneous, open or laparoscopic energy ablation of a renal mass.

Exclusion Criteria

Patients not having undergone, or considered candidates for percutaneous, open or laparoscopic energy ablation of a renal mass
Non-English speaking patients
Patients under the age of 18.

Arm && Interventions

Group	Intervention	Description
renal mass ablation candidates	(EORTC QLQ-C30) questionnaire	Standard of care interventions for the treatment of renal masses using energy ablation will be studied. Data collection can be divided into five basic categories: 1) Patient demographics and relevant history, 2) Renal mass characteristics, 3) Ablation procedure details, 4) Imaging studies, and 5) Patient-reported quality of life.
renal mass ablation candidates	EuroQol EQ-5D 7-item questionnaire	Standard of care interventions for the treatment of renal masses using energy ablation will be studied. Data collection can be divided into five basic categories: 1) Patient demographics and relevant history, 2) Renal mass characteristics, 3) Ablation procedure details, 4) Imaging studies, and 5) Patient-reported quality of life.

Primary Outcome Measures

Name	Time	Method
assess renal ablation outcomes	5 years	To assess renal ablation outcomes using standard quality of life measures. Specifically, quality of life outcomes measures will be analyzed with respect to ablation procedure characteristics including ablation technique and anesthesia type as well as renal mass characteristics such as size, location and pathologic tumor type.

Secondary Outcome Measures

Name	Time	Method
differences in imaging characteristics	5 years	between CT and MR related to renal ablation. We hypothesize that, after ablation, the observed relative change in contrast enhancement at the site of ablation for each follow-up time point will be similar for tumors imaged by CT compared with those imaged by MR. This objective will be met by observational and descriptive methods.
Assess the progression of imaging findings	5 years	in terms of size and contrast enhancement at the site of renal ablation, correlated with ablation technology and tumor histopathology. The objective is to determine whether the choice of imaging method, ablation technique, or histopathologic tumor subtype will be associated with similar relative change in contrast enhancement and size after ablation.
Radiation exposure	5 years	associated with CT imaging performed during an ablation procedure and subsequent imaging follow-up to 2 years. Radiation dose will be analyzed using multivariable linear regression, with ablation technique as the primary predictor.

Locations (6): Md Anderson Cancer Center
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Houston, Texas, United States
University of California, Los Angeles
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Los Angeles, California, United States
University of Maryland Medical Center
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Baltimore, Maryland, United States
Memorial Sloan Kettering Cancer Center
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New York, New York, United States
Thomas Jefferson University Hospital
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Philadelphia, Pennsylvania, United States
Rhode Island Hospital
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Providence, Rhode Island, United States