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

NCT01888198 | Active Not Recruiting

• 1 other identifier: MSKCC 13-116
• Study Type: observational
• Target: 294
• Locations: 1 country
• Sites: 6

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

Conditions

Renal Cancer

Keywords

ablation; quality of Life (QOL); kidney; registry; Ablation of Renal Masses Outcomes Registry (ARMOR); 13-116

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• differences in imaging characteristics

  5 years

• Assess the progression of imaging findings

  5 years

• Radiation exposure

  5 years

Study Arms (1)

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; Behavioral: EuroQol EQ-5D 7-item questionnaire

Interventions

(EORTC QLQ-C30) questionnaire BEHAVIORAL

Also known as: European Organization for Research and Treatment of Cancer 30-item

renal mass ablation candidates

EuroQol EQ-5D 7-item questionnaire BEHAVIORAL

renal mass ablation candidates

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (6)

University of California, Los Angeles

Los Angeles, California, 90095, United States

Location

University of Maryland Medical Center

Baltimore, Maryland, 21201, United States

Location

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, 19107, United States

Location

Rhode Island Hospital

Providence, Rhode Island, 02903, United States

Location

Md Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• Memorial Sloan Kettering Cancer Center

MeSH Terms

Conditions

Kidney Neoplasms

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Fourat Ridouani, MD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 24 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 24, 2013
• First Posted: June 27, 2013
• Study Start: June 1, 2013
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: July 25, 2025

Record last verified: 2025-07

Locations

US (6)