- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01117779
Tracking Renal Tumors After Cryoablation Evaluation (TRACE)
April 18, 2023 updated by: Boston Scientific Corporation
Tracking Renal Tumors After Cryoablation Evaluation (TRACE) Registry
TRACE is an observational, open-label, single-arm, multi-center registry of subjects who have undergone renal lesion cryoablation per their physician's standard of care.
Patients 18 years of age or older who have been determined to be an appropriate candidate for cryoablation will be offered enrollment into the registry.
Subjects will be observed for five years from the date of their cryoablation procedure.
Study Overview
Detailed Description
The registry is non-interventional; it will neither direct the cryoablation procedures performed nor define the post-surgery follow-up of each subject.
A subject's participation in the registry will not influence or direct subject treatment procedures or follow-up care.
Physicians will use their discretion and personal standards of care to select subjects, perform the cryoablation procedures and define appropriate follow-up visit schedules for their subjects; it is anticipated that subjects will be seen at least once per year during the five-year follow-up period of TRACE.
Subjects may be followed by the physician performing the cryoablation procedure or by their local/personal physician.
The enrolling physician will be responsible for providing the follow-up data to the registry and will, as appropriate, work with a subject's local/personal physician to collect the follow-up data.
Study Type
Observational
Enrollment (Actual)
246
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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California
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Orange, California, United States, 92868
- University of California Irvine
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-
Colorado
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Denver, Colorado, United States, 80205
- Kaiser Permanente
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Kentucky
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Lexington, Kentucky, United States, 40536
- University of Kentucky
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Nebraska
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Omaha, Nebraska, United States, 68198
- University of Nebraska Medical Center
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New York
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New York, New York, United States, 10032
- Columbia University
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South Carolina
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Charleston, South Carolina, United States, 29425
- Medical University of South Carolina
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Tennessee
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Nashville, Tennessee, United States, 37232
- Vanderbilt University
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
Academic medical centers and community-based physicians
Description
Suggested Inclusion Criteria:
- Patient is at least 18 years of age.
- Patient has a renal lesion suspicious for malignancy.
- Patient is to undergo renal lesion cryoablation via a Galil Medical cryoablation system using Galil Medical needles for treatment of primary or recurrent disease.
- Patient is to be available for long-term follow-up per the enrolling physician's standard care practices.
- Patient has provided written informed consent.
Suggested Exclusion Criteria:
- Patient is either currently using or has used within the last 30 days an investigational product of any type.
- Patient has metastatic disease to or from the kidney.
- Patient has had previous therapy on the index lesion (e.g. radiofrequency, cryoablation, partial nephrectomy).
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Kidney lesions amenable to cryoablation
Kidney lesions treated with cryoablation.
|
Cryoablation (freezing) with Galil Medical cryoablation systems and needles under imaging guidance
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes in Lesion Size
Time Frame: Baseline and months 6, 12, 24, 36, 48 and 60
|
Changes to lesion size using greatest trans-axial diameter (cm) from baseline through the follow-up intervals.
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Baseline and months 6, 12, 24, 36, 48 and 60
|
Renal Function Status
Time Frame: Baseline and months 6, 12, 24, 36, 48 and 60
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Determined by the estimated Median Glomerular Filtration Rate (eGFR) measure using mL/min
|
Baseline and months 6, 12, 24, 36, 48 and 60
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Hospital Stay
Time Frame: Average duration of 2 days or longer
|
Length of time in hospital is the duration of the patient's in-hospital time measured in hours, from intervention to discharge with the average duration of hospitalization being 2 days but could be much longer.
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Average duration of 2 days or longer
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Post-cryoablation Lesion Recurrence With Enhancement
Time Frame: Months 6, 12, 24, 36, 48 and 60
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Lesions with imaging that showed contrast enhancement based on investigator assessment.
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Months 6, 12, 24, 36, 48 and 60
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Disease-specific Survival Rates
Time Frame: Month 60
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Disease-specific survival rate is the time in days from cryoprocedure to death due to kidney cancer.
Subjects who are alive will be censored at date of their last visit.
Subjects who have died from causes other than kidney cancer will be censored at the time of death.
Patients are followed up for duration of registry which is 5 years.
|
Month 60
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Overall Survival Rates
Time Frame: Month 60
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Death due to any cause
|
Month 60
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Quality of Life Assessment
Time Frame: Months 6 and 12
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QoL SF12 is a health status survey to monitor outcomes in general and specific populations.
Scoring system for the SF12 is norm-based scoring (NBS).
This rescaling is done by linear transformation.The scale for each component is provided where the min = worst health and max= best health.
Scale range (min-max,range): GH 23.9-63.7,39.8;
PF 25.6-57.1,31.5 ; RP 23.6-57.5, 33.9; BP 21.7-57.7,36.1;
VT 29.4-68.7,
39.4; SF 21.3-56.9,35.6;
RE 14.7-56.3,41.6;
HM 18.3-64.2,45.9;
PCS 9.9-76,66 MCS 3.2-77.9,74.7
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Months 6 and 12
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Development of Metastatic Disease.
Time Frame: Month 60
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Time between cryotherapy and first evidence of metastatic disease
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Month 60
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Total Number of Recurrences
Time Frame: Month 60
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Total recurrences based on imaging with enhancement and retreatments (eg: nephrectomy, partial nephrectomy or ablation).
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Month 60
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Procedure Method Outcomes
Time Frame: During the procedure and immediately after it, an average of 2 hours.
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An assessment of outcomes across laparoscopic-assisted, percutaneous and open cryoablation procedures.
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During the procedure and immediately after it, an average of 2 hours.
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Standard of Care Follow-up Procedures
Time Frame: These outcomes are measured at each follow-up visit out to 5 years post-cryo procedure
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Characterization of standards of care for cryoablation procedure follow-up across the participating registry centers.
|
These outcomes are measured at each follow-up visit out to 5 years post-cryo procedure
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Stephen Savage, MD, Medical University of South Carolina
- Study Chair: Peter Clark, MD, Wake Forest University Health Sciences
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Goldfarb HA. Nd:YAG laser laparoscopic coagulation of symptomatic myomas. J Reprod Med. 1992 Jul;37(7):636-8.
- Saliken JC, Donnelly BJ, Rewcastle JC. The evolution and state of modern technology for prostate cryosurgery. Urology. 2002 Aug;60(2 Suppl 1):26-33. doi: 10.1016/s0090-4295(02)01681-3.
- Rewcastle JC, Sandison GA, Saliken JC, Donnelly BJ, McKinnon JG. Considerations during clinical operation of two commercially available cryomachines. J Surg Oncol. 1999 Jun;71(2):106-11. doi: 10.1002/(sici)1096-9098(199906)71:23.0.co;2-z.
- Rewcastle JC, Hahn LJ, Saliken JC, McKinnon JG. Use of a moratorium to achieve consistent liquid nitrogen cryoprobe performance. J Surg Oncol. 1997 Oct;66(2):110-3. doi: 10.1002/(sici)1096-9098(199710)66:23.0.co;2-g.
- Levey AS, Bosch JP, Lewis JB, Greene T, Rogers N, Roth D. A more accurate method to estimate glomerular filtration rate from serum creatinine: a new prediction equation. Modification of Diet in Renal Disease Study Group. Ann Intern Med. 1999 Mar 16;130(6):461-70. doi: 10.7326/0003-4819-130-6-199903160-00002.
- Finley DS, Beck S, Box G, Chu W, Deane L, Vajgrt DJ, McDougall EM, Clayman RV. Percutaneous and laparoscopic cryoablation of small renal masses. J Urol. 2008 Aug;180(2):492-8; discussion 498. doi: 10.1016/j.juro.2008.04.019. Epub 2008 Jun 11.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 9, 2010
Primary Completion (Actual)
November 24, 2020
Study Completion (Actual)
November 24, 2020
Study Registration Dates
First Submitted
May 4, 2010
First Submitted That Met QC Criteria
May 4, 2010
First Posted (Estimated)
May 5, 2010
Study Record Updates
Last Update Posted (Estimated)
January 19, 2024
Last Update Submitted That Met QC Criteria
April 18, 2023
Last Verified
April 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CUC10-RNL02
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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