Clinical trial NCT01117779: Tracking Renal Tumors After Cryoablation Evaluation
Official title: Tracking Renal Tumors After Cryoablation Evaluation (TRACE) Registry
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Kidney Neoplasms
Keywords: kidney tumors
renal tumors
renal cell carcinoma
kidney lesions
renal lesions
cryoablation
cryotherapy
cryosurgery
Lead sponsor: Boston Scientific Corporation
Sponsor class: INDUSTRY
First posted: 2010-05-05
Enrollment: 246
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Academic medical centers and community-based physicians

Brief summary: 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.

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.

Eligibility criteria: 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).

Primary outcomes:
measure: Changes in Lesion Size
timeFrame: Baseline and months 6, 12, 24, 36, 48 and 60
measure: Renal Function Status
timeFrame: Baseline and months 6, 12, 24, 36, 48 and 60
measure: Hospital Stay
timeFrame: Average duration of 2 days or longer
measure: Post-cryoablation Lesion Recurrence With Enhancement
timeFrame: Months 6, 12, 24, 36, 48 and 60
measure: Disease-specific Survival Rates
timeFrame: Month 60
measure: Overall Survival Rates
timeFrame: Month 60
measure: Quality of Life Assessment
timeFrame: Months 6 and 12
measure: Development of Metastatic Disease.
timeFrame: Month 60
measure: Total Number of Recurrences
timeFrame: Month 60
Secondary outcomes:
measure: Procedure Method Outcomes
timeFrame: During the procedure and immediately after it, an average of 2 hours.
measure: Standard of Care Follow-up Procedures
timeFrame: These outcomes are measured at each follow-up visit out to 5 years post-cryo procedure
Other outcomes:
Locations:
city: Orange
country: United States
facility: University of California Irvine
state: California
city: Denver
country: United States
facility: Kaiser Permanente
state: Colorado
city: Lexington
country: United States
facility: University of Kentucky
state: Kentucky
city: Omaha
country: United States
facility: University of Nebraska Medical Center
state: Nebraska
city: New York
country: United States
facility: Columbia University
state: New York
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Nashville
country: United States
facility: Vanderbilt University
state: Tennessee
Study officials:
affiliation: Medical University of South Carolina
name: Stephen Savage, MD
role: STUDY_CHAIR
affiliation: Wake Forest University Health Sciences
name: Peter Clark, MD
role: STUDY_CHAIR
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citation: 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.
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citation: 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.