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

N/AActive Not RecruitingNCT01888198

Memorial Sloan Kettering Cancer Center294 enrolled

Overview

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

Study Type

OBSERVATIONAL

Enrollment

294

Conditions

Renal Cancer

Interventions

(EORTC QLQ-C30) questionnaireBEHAVIORAL

EuroQol EQ-5D 7-item questionnaireBEHAVIORAL

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (6)

University of California, Los Angeles

Los Angeles, California, United States

University of Maryland Medical Center

Baltimore, Maryland, United States

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, United States

Outcomes

Primary Outcomes

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.

Time frame: 5 years

Secondary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: 5 years

Data from ClinicalTrials.gov

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