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

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 Overview

• Status: Active, not recruiting
• Conditions: Renal Cancer
• Intervention / Treatment: Behavioral: (EORTC QLQ-C30) questionnaire; Behavioral: EuroQol EQ-5D 7-item questionnaire

• Study Type: Observational
• Enrollment (Estimated): 294

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90095
      • University of California, Los Angeles
  • Maryland
    • Baltimore, Maryland, United States, 21201
      • University of Maryland Medical Center
  • New York
    • New York, New York, United States, 10065
      • Memorial Sloan Kettering Cancer Center
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19107
      • Thomas Jefferson University Hospital
  • Rhode Island
    • Providence, Rhode Island, United States, 02903
      • Rhode Island Hospital
  • Texas
    • Houston, Texas, United States, 77030
      • MD Anderson Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The patients at MSKCC will be identified and recruited from the existing patient population in the Interventional Radiology Service in the Department of Radiology. At all other participating sites, patients meeting eligibility criteria will be identified by the site investigators that have received the referral for consideration of renal mass ablation. Participation in ARMOR may involve retrospective data collection only, combined retrospective and prospective data collection, or prospective data collection

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Other

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
renal mass ablation candidates; 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; Other Names: European Organization for Research and Treatment of Cancer 30-item; Behavioral: EuroQol EQ-5D 7-item questionnaire

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Memorial Sloan Kettering Cancer Center
• Collaborators: M.D. Anderson Cancer Center; University of California, Los Angeles; Icahn School of Medicine at Mount Sinai; University of California, San Francisco; Dartmouth-Hitchcock Medical Center; University Hospital, Bordeaux; Rhode Island Hospital; Thomas Jefferson University; Barbara Ann Karmanos Cancer Institute; Hospital Sirio-Libanes; University of Maryland, Baltimore County; San Diego Imaging Medical Group
• Investigators: Principal Investigator: Fourat Ridouani, MD, Memorial Sloan Kettering Cancer Center

Publications and helpful links

Helpful Links

• Memorial Sloan Kettering Cancer Center

Study record dates

Study Major Dates

• Study Start: June 1, 2013
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026

Study Registration Dates

• First Submitted: June 24, 2013
• First Submitted That Met QC Criteria: June 25, 2013
• First Posted (Estimated): June 27, 2013

Study Record Updates

• Last Update Posted (Actual): July 25, 2025
• Last Update Submitted That Met QC Criteria: July 24, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: kidney; ablation; registry; quality of Life (QOL); Ablation of Renal Masses Outcomes Registry (ARMOR); 13-116
• Additional Relevant MeSH Terms: Urogenital Diseases; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urologic Neoplasms; Kidney Neoplasms
• Other Study ID Numbers: MSKCC 13-116