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

Study Overview
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Brief Summary
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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

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

Conditions
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Renal Cancer

Intervention / Treatment
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* Behavioral: (EORTC QLQ-C30) questionnaire
* Behavioral: EuroQol EQ-5D 7-item questionnaire


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| renal mass ablation candidates<br>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. | Behavioral: (EORTC QLQ-C30) questionnaire<br> <br> * Other names: European Organization for Research and Treatment of Cancer 30-item;Behavioral: EuroQol EQ-5D 7-item questionnaire<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| assess renal ablation outcomes | 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. | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| differences in imaging characteristics | 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. | 5 years | 
| Assess the progression of imaging findings | 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. | 5 years | 
| Radiation exposure | 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. | 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ablation, quality of Life (QOL), kidney, registry, Ablation of Renal Masses Outcomes Registry (ARMOR), 13-116