Renal CancerNCT01888198
Ablation of Renal Masses Outcomes Registry (ARMOR): Ablation Procedure and Quality of Life Assessment
An observational study of Renal Cancer, run by Memorial Sloan Kettering Cancer Center at 6 sites in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Cancer
- What is being tested?
- (EORTC QLQ-C30) questionnaire and EuroQol EQ-5D 7-item questionnaire
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 294 participants
- Where
- 6 sitesUnited States
- Study dates
- Jun 2013to Jun 2027
- How long will I take part?
- 24 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
University of Maryland Medical Center
Baltimore, Maryland, 21201
Md Anderson Cancer Center
Houston, Texas, 77030
University of California, Los Angeles
Los Angeles, California, 90095
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107
Rhode Island Hospital
Providence, Rhode Island, 02903
About this study
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
- Conditions
- Renal Cancer
- Being tested
- (EORTC QLQ-C30) questionnaire, EuroQol EQ-5D 7-item questionnaire
- Keywords
- ablation, quality of Life (QOL), kidney, registry, Ablation of Renal Masses Outcomes Registry (ARMOR), 13-116
- Medical subject headings
- Kidney Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
(EORTC QLQ-C30) questionnaireBehavioural
Also called European Organization for Research and Treatment of Cancer 30-item
EuroQol EQ-5D 7-item questionnaireBehavioural
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: (EORTC QLQ-C30) questionnaire; Behavioral: EuroQol EQ-5D 7-item questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 5 years
Secondary outcomes (3)
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.
Measured: 5 years
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.
Measured: 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.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2013 (estimated)
- Study startJun 2013
- Primary completionJun 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal CancerStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 294 participants (estimated)
- Target duration
- 24 Months
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- 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, University Hospital, Bordeaux, University of California, Los Angeles
- Responsible party
- Sponsor
- Investigators
- Fourat Ridouani, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01888198
- Sponsor's protocol ID
- MSKCC 13-116
- Status last verified
- Jul 2026
- First submitted
- 24 Jun 2013
- Last updated
- 2 Jul 2026
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ablation of Renal Masses Outcomes Registry (ARMOR): Ablation Procedure and Quality of Life Assessment
- ClinicalTrials.gov ID
- NCT01888198
- Acronym / sponsor ID
- MSKCC 13-116
- Conditions
- Renal Cancer
- Keywords
- ablation, quality of Life (QOL), kidney, registry, Ablation of Renal Masses Outcomes Registry (ARMOR), 13-116
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 294 participants (estimated)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- 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, University Hospital, Bordeaux, University of California, Los Angeles
- Study start
- Jun 2013
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 27 Jun 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 24 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| renal mass ablation candidates | – | Behavioral: (EORTC QLQ-C30) questionnaire, Behavioral: EuroQol EQ-5D 7-item questionnaireStandard 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (4 listed)
- Patients having undergone percutaneous, open or laparoscopic energy ablation of a renal mass.
- Patients scheduled to undergo, rather than having undergone, percutaneous, open or laparoscopic energy ablation of a renal mass.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| (EORTC QLQ-C30) questionnaireAlso: European Organization for Research and Treatment of Cancer 30-item | Behavioural | renal mass ablation candidates |
| EuroQol EQ-5D 7-item questionnaire | Behavioural | renal mass ablation candidates |
Primary outcome
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.
3 secondary outcomes
differences in imaging characteristics
Time frame: 5 years
Assess the progression of imaging findings
Time frame: 5 years
Radiation exposure
Time frame: 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2026.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fourat Ridouani, MD principal investigator
Memorial Sloan Kettering Cancer Center
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Renal Cancer, run by Memorial Sloan Kettering Cancer Center at 6 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 2 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
assess renal ablation outcomes (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2026.