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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01888198
Enrollment
294
Registered
2013-06-27
Start date
2013-06-01
Completion date
2027-06-01
Last updated
2026-07-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Renal Cancer

Keywords

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

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

Interventions

BEHAVIORAL(EORTC QLQ-C30) questionnaire
BEHAVIORALEuroQol EQ-5D 7-item questionnaire

Sponsors

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

Study design

Observational model
COHORT
Time perspective
OTHER

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
assess renal ablation outcomes5 yearsTo 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

MeasureTime frameDescription
differences in imaging characteristics5 yearsbetween 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 findings5 yearsin 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 exposure5 yearsassociated 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.

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORFourat Ridouani, MD

Memorial Sloan Kettering Cancer Center

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 3, 2026