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| Name | Class |
|---|---|
| Rhode Island Hospital | OTHER |
| M.D. Anderson Cancer Center | OTHER |
| University of California, San Francisco | OTHER |
| Thomas Jefferson University |
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| (EORTC QLQ-C30) questionnaire | Behavioral |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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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:
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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
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| Name | Affiliation | Role |
|---|---|---|
| Fourat Ridouani, MD | Memorial Sloan Kettering Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, Los Angeles | Los Angeles | California | 90095 | United States | ||
| University of Maryland Medical Center |
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| Label | URL |
|---|---|
| Memorial Sloan Kettering Cancer Center | View source |
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| OTHER |
| Barbara Ann Karmanos Cancer Institute | OTHER |
| Icahn School of Medicine at Mount Sinai | OTHER |
| University of Maryland, Baltimore County | OTHER |
| Dartmouth-Hitchcock Medical Center | OTHER |
| San Diego Imaging Medical Group | UNKNOWN |
| Hospital Sirio-Libanes | OTHER |
| University Hospital, Bordeaux | OTHER |
| University of California, Los Angeles | OTHER |
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| EuroQol EQ-5D 7-item questionnaire | Behavioral |
|
| 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 |
| 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 |
| Baltimore |
| Maryland |
| 21201 |
| United States |
| Memorial Sloan Kettering Cancer Center | New York | New York | 10065 | United States |
| Thomas Jefferson University Hospital | Philadelphia | Pennsylvania | 19107 | United States |
| Rhode Island Hospital | Providence | Rhode Island | 02903 | United States |
| Md Anderson Cancer Center | Houston | Texas | 77030 | United States |
| ID | Term |
|---|---|
| D007680 | Kidney Neoplasms |
| ID | Term |
|---|---|
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
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| ID | Term |
|---|---|
| D011795 | Surveys and Questionnaires |
| ID | Term |
|---|---|
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
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