Tracking Renal Tumors After Cryoablation Evaluation

Terminated

Conditions: Kidney Neoplasms

Interventions: Device: Cryoablation

Registration Number: NCT01117779

Lead Sponsor: Boston Scientific Corporation

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.

Recruitment & Eligibility

Status: TERMINATED

Sex: All

Target Recruitment: 246

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 & Design

Study Type: OBSERVATIONAL

Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Kidney lesions amenable to cryoablation	Cryoablation	Kidney lesions treated with cryoablation.

Primary Outcome Measures

Name	Time	Method
Renal Function Status	Baseline and months 6, 12, 24, 36, 48 and 60	Determined by the estimated Median Glomerular Filtration Rate (eGFR) measure using mL/min
Total Number of Recurrences	Month 60	Total recurrences based on imaging with enhancement and retreatments (eg: nephrectomy, partial nephrectomy or ablation).
Quality of Life Assessment	Months 6 and 12	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
Changes in Lesion Size	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.
Disease-specific Survival Rates	Month 60	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.
Overall Survival Rates	Month 60	Death due to any cause
Development of Metastatic Disease.	Month 60	Time between cryotherapy and first evidence of metastatic disease
Hospital Stay	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.
Post-cryoablation Lesion Recurrence With Enhancement	Months 6, 12, 24, 36, 48 and 60	Lesions with imaging that showed contrast enhancement based on investigator assessment.

Secondary Outcome Measures

Name	Time	Method
Procedure Method Outcomes	During the procedure and immediately after it, an average of 2 hours.	An assessment of outcomes across laparoscopic-assisted, percutaneous and open cryoablation procedures.
Standard of Care Follow-up Procedures	These outcomes are measured at each follow-up visit out to 5 years post-cryo procedure	Characterization of standards of care for cryoablation procedure follow-up across the participating registry centers.

Trial Locations

Locations (7): University of California Irvine
🇺🇸
Orange, California, United States
Kaiser Permanente
🇺🇸
Denver, Colorado, United States
University of Kentucky
🇺🇸
Lexington, Kentucky, United States
Columbia University
🇺🇸
New York, New York, United States
University of Nebraska Medical Center
🇺🇸
Omaha, Nebraska, United States
Vanderbilt University
🇺🇸
Nashville, Tennessee, United States
Medical University of South Carolina
🇺🇸
Charleston, South Carolina, United States