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

Renal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01888198
• Other study ID #: MSKCC 13-116
• Status: Active, not recruiting
• Start date: June 2013
• Est. completion date: June 2024

Study information

• Verified date: April 2024
• Source: Memorial Sloan Kettering Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 294
• Est. completion date: June 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Kidney Neoplasms
• Renal Cancer

Intervention

Behavioral:
• (EORTC QLQ-C30) questionnaire

• EuroQol EQ-5D 7-item questionnaire

Locations

Country	Name	City	State
United States	University of Maryland Medical Center	Baltimore	Maryland
United States	Md Anderson Cancer Center	Houston	Texas
United States	University of California, Los Angeles	Los Angeles	California
United States	Memorial Sloan Kettering Cancer Center	New York	New York
United States	Thomas Jefferson University Hospital	Philadelphia	Pennsylvania
United States	Rhode Island Hospital	Providence	Rhode Island

Sponsors (13)

Lead Sponsor

Collaborator

Memorial Sloan Kettering Cancer Center

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

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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

External Links

•   Memorial Sloan Kettering Cancer Center