Tracking Renal Tumors After Cryoablation Evaluation (TRACE) Registry
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 246
- 试验地点
- 7
- 主要终点
- Total Number of Recurrences
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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).
结局指标
主要结局
Total Number of Recurrences
时间窗: Month 60
Total recurrences based on imaging with enhancement and retreatments (eg: nephrectomy, partial nephrectomy or ablation).
Renal Function Status
时间窗: Baseline and months 6, 12, 24, 36, 48 and 60
Determined by the estimated Median Glomerular Filtration Rate (eGFR) measure using mL/min
Quality of Life Assessment
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: Month 60
Death due to any cause
Development of Metastatic Disease.
时间窗: Month 60
Time between cryotherapy and first evidence of metastatic disease
Hospital Stay
时间窗: 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
时间窗: Months 6, 12, 24, 36, 48 and 60
Lesions with imaging that showed contrast enhancement based on investigator assessment.
次要结局
- Procedure Method Outcomes(During the procedure and immediately after it, an average of 2 hours.)
- Standard of Care Follow-up Procedures(These outcomes are measured at each follow-up visit out to 5 years post-cryo procedure)