Ablation of Renal Masses Outcomes Registry (ARMOR): Ablation Procedure and Quality of Life Assessment
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|ClinicalTrials.gov Identifier: NCT01888198|
Recruitment Status : Active, not recruiting
First Posted : June 27, 2013
Last Update Posted : September 17, 2020
|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 :||294 participants|
|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 2021|
|Estimated Study Completion Date :||June 2021|
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
- 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.
- 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.
- 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.
- 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.
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
|United States, California|
|University of California, Los Angeles|
|Los Angeles, California, United States, 90095|
|United States, Maryland|
|University of Maryland Medical Center|
|Baltimore, Maryland, United States, 21201|
|United States, New York|
|Memorial Sloan Kettering Cancer Center|
|New York, New York, United States, 10065|
|United States, Pennsylvania|
|Thomas Jefferson University Hospital|
|Philadelphia, Pennsylvania, United States, 19107|
|United States, Rhode Island|
|Rhode Island Hospital|
|Providence, Rhode Island, United States, 02903|
|United States, Texas|
|Md Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Jeremy Durack, MD||Memorial Sloan Kettering Cancer Center|