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

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ClinicalTrials.gov Identifier: NCT01888198
Recruitment Status : Recruiting
First Posted : June 27, 2013
Last Update Posted : February 2, 2018
Sponsor:
Collaborators:
Rhode Island Hospital
M.D. Anderson Cancer Center
University of California, San Francisco
Thomas Jefferson University
Barbara Ann Karmanos Cancer Institute
Icahn School of Medicine at Mount Sinai
University of Maryland, Baltimore County
Dartmouth-Hitchcock Medical Center
San Diego Imaging Medical Group
Hospital Sirio-Libanes
Centre Hospitalier Universitaire De Bordeaux
University of California, Los Angeles
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

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

Condition or disease Intervention/treatment
Renal Cancer Behavioral: (EORTC QLQ-C30) questionnaire Behavioral: EuroQol EQ-5D 7-item questionnaire

Study Type : Observational [Patient Registry]
Estimated Enrollment : 1000 participants
Observational Model: Cohort
Time Perspective: Other
Target Follow-Up Duration: 24 Months
Official Title: Ablation of Renal Masses Outcomes Registry (ARMOR): Ablation Procedure and Quality of Life Assessment
Study Start Date : June 2013
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : June 2019

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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 Name: European Organization for Research and Treatment of Cancer 30-item
Behavioral: EuroQol EQ-5D 7-item questionnaire



Primary Outcome Measures :
  1. assess renal ablation outcomes [ Time Frame: 5 years ]
    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.


Secondary Outcome Measures :
  1. differences in imaging characteristics [ Time Frame: 5 years ]
    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.

  2. Assess the progression of imaging findings [ Time Frame: 5 years ]
    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.

  3. Radiation exposure [ Time Frame: 5 years ]
    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.



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01888198


Contacts
Contact: Jeremy Durack, MD 212-639-4898
Contact: Stephen Solomon, MD 212-639-5012

Locations
United States, California
University of California, Los Angeles Recruiting
Los Angeles, California, United States, 90095
Contact: Steve Raman, MD         
Principal Investigator: Matthew Rettig, MD         
United States, Maryland
University of Maryland Medical Center Recruiting
Baltimore, Maryland, United States, 21201
Contact: Richard Howard, MD         
Principal Investigator: Richard Howard, MD         
United States, New York
Memorial Sloan Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Contact: Jeremy Durack, MD    212-639-4898      
Contact: Stephen Solomon, MD    212-639-5012      
Principal Investigator: Jeremy Durack, MD         
United States, Pennsylvania
Thomas Jefferson University Hospital Active, not recruiting
Philadelphia, Pennsylvania, United States, 19107
United States, Rhode Island
Rhode Island Hospital Active, not recruiting
Providence, Rhode Island, United States, 02903
United States, Texas
Md Anderson Cancer Center Active, not recruiting
Houston, Texas, United States, 77030
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
Rhode Island Hospital
M.D. Anderson Cancer Center
University of California, San Francisco
Thomas Jefferson University
Barbara Ann Karmanos Cancer Institute
Icahn School of Medicine at Mount Sinai
University of Maryland, Baltimore County
Dartmouth-Hitchcock Medical Center
San Diego Imaging Medical Group
Hospital Sirio-Libanes
Centre Hospitalier Universitaire De Bordeaux
University of California, Los Angeles
Investigators
Principal Investigator: Jeremy Durack, MD Memorial Sloan Kettering Cancer Center

Additional Information:
Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT01888198     History of Changes
Other Study ID Numbers: MSKCC 13-116
First Posted: June 27, 2013    Key Record Dates
Last Update Posted: February 2, 2018
Last Verified: February 2018

Keywords provided by Memorial Sloan Kettering Cancer Center:
ablation
quality of Life (QOL)
kidney
registry
Ablation of Renal Masses Outcomes Registry (ARMOR)
13-116

Additional relevant MeSH terms:
Kidney Neoplasms
Carcinoma, Renal Cell
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Kidney Diseases
Urologic Diseases
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type