Clinical trial NCT01888198: Ablation of Renal Masses Outcomes Registry (ARMOR): Ablation Procedure and Quality of Life Assessment
Official title: Ablation of Renal Masses Outcomes Registry (ARMOR): Ablation Procedure and Quality of Life Assessment
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Renal Cancer
Keywords: ablation
quality of Life (QOL)
kidney
registry
Ablation of Renal Masses Outcomes Registry (ARMOR)
13-116
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
Collaborators: name: Rhode Island Hospital
name: M.D. Anderson Cancer Center
name: University of California, San Francisco
name: Thomas Jefferson University
name: Barbara Ann Karmanos Cancer Institute
name: Icahn School of Medicine at Mount Sinai
name: University of Maryland, Baltimore County
name: Dartmouth-Hitchcock Medical Center
name: San Diego Imaging Medical Group
name: Hospital Sirio-Libanes
name: University Hospital, Bordeaux
name: University of California, Los Angeles
First posted: 2013-06-27
Enrollment: 294
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
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

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


Eligibility criteria: 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.

Primary outcomes:
measure: assess renal ablation outcomes
timeFrame: 5 years
Secondary outcomes:
measure: differences in imaging characteristics
timeFrame: 5 years
measure: Assess the progression of imaging findings
timeFrame: 5 years
measure: Radiation exposure
timeFrame: 5 years
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: University of California, Los Angeles
state: California
city: Baltimore
country: United States
facility: University of Maryland Medical Center
state: Maryland
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
city: Philadelphia
country: United States
facility: Thomas Jefferson University Hospital
state: Pennsylvania
city: Providence
country: United States
facility: Rhode Island Hospital
state: Rhode Island
city: Houston
country: United States
facility: Md Anderson Cancer Center
state: Texas
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Fourat Ridouani, MD
role: PRINCIPAL_INVESTIGATOR
References: