Kidney Neoplasms
Conditions
Keywords
kidney tumors, renal tumors, renal cell carcinoma, kidney lesions, renal lesions, cryoablation, cryotherapy, cryosurgery
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.
Interventions
DEVICECryoablation
Cryoablation (freezing) with Galil Medical cryoablation systems and needles under imaging guidance
Sponsors
Boston Scientific Corporation
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Development of Metastatic Disease. | Month 60 | Time between cryotherapy and first evidence of metastatic disease |
| 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. |
| 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 |
| 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. |
| 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Cryoablation Participants with kidney lesions treated with cryoablation.
Cryoablation: Cryoablation (freezing) with Galil Medical cryoablation systems and needles under imaging guidance
There were a total of 246 ITT participants with 145 of those having lesion(s) with biopsy proven Renal Cell Carcinoma (RCC). | 246 |
| Total | 246 |
Baseline characteristics
| Characteristic | Cryoablation |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 156 Participants |
| Age, Categorical Between 18 and 65 years | 90 Participants |
| Age, Continuous | 66.3 years STANDARD_DEVIATION 9.63 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 6 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 240 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Lesion Size | 2.5 cm |
| Quality of Life (QOL) Over time as assessed by the Short Form-12 (SF-12) GM Bodily Pain | 48.710 score on a scale |
| Quality of Life (QOL) Over time as assessed by the Short Form-12 (SF-12) GM General Health | 47.750 score on a scale |
| Quality of Life (QOL) Over time as assessed by the Short Form-12 (SF-12) GM Mental Component Summary | 52.72 score on a scale |
| Quality of Life (QOL) Over time as assessed by the Short Form-12 (SF-12) GM Mental Health | 52.740 score on a scale |
| Quality of Life (QOL) Over time as assessed by the Short Form-12 (SF-12) GM Physical Component Summary | 46.930 score on a scale |
| Quality of Life (QOL) Over time as assessed by the Short Form-12 (SF-12) GM Physical Functioning | 49.190 score on a scale |
| Quality of Life (QOL) Over time as assessed by the Short Form-12 (SF-12) GM Role Emotional | 56.280 score on a scale |
| Quality of Life (QOL) Over time as assessed by the Short Form-12 (SF-12) GM Role Physical | 49.000 score on a scale |
| Quality of Life (QOL) Over time as assessed by the Short Form-12 (SF-12) GM Social Functioning | 48.010 score on a scale |
| Quality of Life (QOL) Over time as assessed by the Short Form-12 (SF-12) GM Vitality | 49.070 score on a scale |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants |
| Race (NIH/OMB) Black or African American | 35 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 6 Participants |
| Race (NIH/OMB) White | 203 Participants |
| Region of Enrollment United States | 246 participants |
| Sex: Female, Male Female | 90 Participants |
| Sex: Female, Male Male | 156 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 26 / 246 |
| other Total, other adverse events | 33 / 246 |
| serious Total, serious adverse events | 11 / 246 |
Outcome results
Primary
Changes in Lesion Size
Changes to lesion size using greatest trans-axial diameter (cm) from baseline through the follow-up intervals.
Time frame: Baseline and months 6, 12, 24, 36, 48 and 60
Population: Participants for whom cryoablation via GALIL Medical Cryoablation system was performed with available data at the respective time point.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Cryoablation | Changes in Lesion Size | Baseline | 2.5 cm |
| Cryoablation | Changes in Lesion Size | Month 6 | -0.2 cm |
| Cryoablation | Changes in Lesion Size | Month 12 | -0.4 cm |
| Cryoablation | Changes in Lesion Size | Month 24 | -0.8 cm |
| Cryoablation | Changes in Lesion Size | Month 36 | -1.0 cm |
| Cryoablation | Changes in Lesion Size | Month 48 | -1.0 cm |
| Cryoablation | Changes in Lesion Size | Month 60 | -1.0 cm |
Primary
Development of Metastatic Disease.
Time between cryotherapy and first evidence of metastatic disease
Time frame: Month 60
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Cryoablation | Development of Metastatic Disease. | 18.7 months |
Primary
Disease-specific Survival Rates
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.
Time frame: Month 60
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cryoablation | Disease-specific Survival Rates | Alive | 221 Participants |
| Cryoablation | Disease-specific Survival Rates | Death due to other causes | 25 Participants |
Primary
Hospital Stay
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.
Time frame: Average duration of 2 days or longer
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Cryoablation | Hospital Stay | 29.3 hours |
Primary
Overall Survival Rates
Death due to any cause
Time frame: Month 60
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cryoablation | Overall Survival Rates | Not censored (death) | 25 Participants |
| Cryoablation | Overall Survival Rates | Censored | 221 Participants |
Primary
Post-cryoablation Lesion Recurrence With Enhancement
Lesions with imaging that showed contrast enhancement based on investigator assessment.
Time frame: Months 6, 12, 24, 36, 48 and 60
Population: Lesion recurrence with enhancement
| Arm | Measure | Group | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| Cryoablation | Post-cryoablation Lesion Recurrence With Enhancement | Month 6 | 4 lesions |
| Cryoablation | Post-cryoablation Lesion Recurrence With Enhancement | Month 12 | 3 lesions |
| Cryoablation | Post-cryoablation Lesion Recurrence With Enhancement | Month 24 | 4 lesions |
| Cryoablation | Post-cryoablation Lesion Recurrence With Enhancement | Month 36 | 1 lesions |
| Cryoablation | Post-cryoablation Lesion Recurrence With Enhancement | Month 48 | 4 lesions |
| Cryoablation | Post-cryoablation Lesion Recurrence With Enhancement | Month 60 | 1 lesions |
Primary
Quality of Life Assessment
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
Time frame: Months 6 and 12
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Cryoablation | Quality of Life Assessment | Vitality at month 12 | 49.070 score on a scale |
| Cryoablation | Quality of Life Assessment | General Health at month 6 | 47.750 score on a scale |
| Cryoablation | Quality of Life Assessment | General Health at month 12 | 47.750 score on a scale |
| Cryoablation | Quality of Life Assessment | Physical Functioning at month 6 | 41.320 score on a scale |
| Cryoablation | Quality of Life Assessment | Physical Functioning at month 12 | 49.190 score on a scale |
| Cryoablation | Quality of Life Assessment | Role Physical at month 6 | 44.770 score on a scale |
| Cryoablation | Quality of Life Assessment | Role Physical at month 12 | 49.000 score on a scale |
| Cryoablation | Quality of Life Assessment | Bodily Pain at month 6 | 48.710 score on a scale |
| Cryoablation | Quality of Life Assessment | Bodily Pain at month 12 | 48.710 score on a scale |
| Cryoablation | Quality of Life Assessment | Vitality at month 6 | 49.070 score on a scale |
| Cryoablation | Quality of Life Assessment | Social Functioning at month 6 | 48.010 score on a scale |
| Cryoablation | Quality of Life Assessment | Social Functioning at month 12 | 48.010 score on a scale |
| Cryoablation | Quality of Life Assessment | Mental Health at month 6 | 52.740 score on a scale |
| Cryoablation | Quality of Life Assessment | Mental Health at month 12 | 52.740 score on a scale |
| Cryoablation | Quality of Life Assessment | Role Emotional at month 6 | 51.080 score on a scale |
| Cryoablation | Quality of Life Assessment | Role Emotional at month 12 | 51.080 score on a scale |
| Cryoablation | Quality of Life Assessment | Physical Component Summary at month 6 | 44.990 score on a scale |
| Cryoablation | Quality of Life Assessment | Physical Component Summary at month 12 | 45.690 score on a scale |
| Cryoablation | Quality of Life Assessment | Mental Component summary at month 6 | 52.720 score on a scale |
| Cryoablation | Quality of Life Assessment | Mental Component summary at month 12 | 52.320 score on a scale |
Primary
Renal Function Status
Determined by the estimated Median Glomerular Filtration Rate (eGFR) measure using mL/min
Time frame: Baseline and months 6, 12, 24, 36, 48 and 60
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Cryoablation | Renal Function Status | Month 48 | 59.50 ml/min |
| Cryoablation | Renal Function Status | Month 60 | 60.00 ml/min |
| Cryoablation | Renal Function Status | Baseline | 64.9 ml/min |
| Cryoablation | Renal Function Status | Month 6 | 60.3 ml/min |
| Cryoablation | Renal Function Status | Month 12 | 59.75 ml/min |
| Cryoablation | Renal Function Status | Month 24 | 59.72 ml/min |
| Cryoablation | Renal Function Status | Month 36 | 57.51 ml/min |
Primary
Total Number of Recurrences
Total recurrences based on imaging with enhancement and retreatments (eg: nephrectomy, partial nephrectomy or ablation).
Time frame: Month 60
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cryoablation | Total Number of Recurrences | 18 recurrence |
Secondary
Procedure Method Outcomes
An assessment of outcomes across laparoscopic-assisted, percutaneous and open cryoablation procedures.
Time frame: During the procedure and immediately after it, an average of 2 hours.
Population: Participants treated with laparoscopic, percutaneous, or open procedure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cryoablation | Procedure Method Outcomes | Procedure Method: Laparoscopic | 99 participants |
| Cryoablation | Procedure Method Outcomes | Procedure Method: Percutaneous | 146 participants |
| Cryoablation | Procedure Method Outcomes | Procedure Method: Open | 1 participants |
| Cryoablation | Procedure Method Outcomes | Number of lesions treated with cryoablation is One | 242 participants |
| Cryoablation | Procedure Method Outcomes | Number of lesions treated with cryoablation is Two | 2 participants |
| Cryoablation | Procedure Method Outcomes | Number of lesions treated with cryoablation is Three | 2 participants |
| Cryoablation | Procedure Method Outcomes | Type of hemostatic agents or maneuvers used is None | 154 participants |
| Cryoablation | Procedure Method Outcomes | Type of hemostatic agents or maneuvers used=Compression | 6 participants |
| Cryoablation | Procedure Method Outcomes | Type of hemostatic agents or maneuvers used=Suturing | 4 participants |
| Cryoablation | Procedure Method Outcomes | Type of hemostatic agents or maneuvers used=Floseal | 74 participants |
| Cryoablation | Procedure Method Outcomes | Type of hemostatic agens or maneuvers used=Surgical | 79 participants |
| Cryoablation | Procedure Method Outcomes | Type of hemostatic agents or maneuversed used=Other | 2 participants |
| Cryoablation | Procedure Method Outcomes | Method of monitoring iceball formation=CT | 145 participants |
| Cryoablation | Procedure Method Outcomes | Method of monitoring iceball formation=Ultrasound | 100 participants |
| Cryoablation | Procedure Method Outcomes | Number of freeze/thaw cycles=0* | 1 participants |
| Cryoablation | Procedure Method Outcomes | Number of freeze/thaw cycles=2 | 228 participants |
| Cryoablation | Procedure Method Outcomes | Number of freeze/thaw cycles=3 | 12 participants |
| Cryoablation | Procedure Method Outcomes | Number of freeze/thaw cycles=4 | 5 participants |
| Cryoablation | Procedure Method Outcomes | Complications (malfunction of cryoablation system) | 3 participants |
| Cryoablation | Procedure Method Outcomes | Intra-operative patient complications | 13 participants |
| RENAL CELL CARCINOMA (RCC) POPULATION | Procedure Method Outcomes | Number of freeze/thaw cycles=4 | 2 participants |
| RENAL CELL CARCINOMA (RCC) POPULATION | Procedure Method Outcomes | Procedure Method: Laparoscopic | 63 participants |
| RENAL CELL CARCINOMA (RCC) POPULATION | Procedure Method Outcomes | Type of hemostatic agens or maneuvers used=Surgical | 52 participants |
| RENAL CELL CARCINOMA (RCC) POPULATION | Procedure Method Outcomes | Procedure Method: Percutaneous | 81 participants |
| RENAL CELL CARCINOMA (RCC) POPULATION | Procedure Method Outcomes | Number of freeze/thaw cycles=2 | 133 participants |
| RENAL CELL CARCINOMA (RCC) POPULATION | Procedure Method Outcomes | Procedure Method: Open | 1 participants |
| RENAL CELL CARCINOMA (RCC) POPULATION | Procedure Method Outcomes | Type of hemostatic agents or maneuversed used=Other | 2 participants |
| RENAL CELL CARCINOMA (RCC) POPULATION | Procedure Method Outcomes | Number of lesions treated with cryoablation is One | 144 participants |
| RENAL CELL CARCINOMA (RCC) POPULATION | Procedure Method Outcomes | Intra-operative patient complications | 9 participants |
| RENAL CELL CARCINOMA (RCC) POPULATION | Procedure Method Outcomes | Number of lesions treated with cryoablation is Two | 1 participants |
| RENAL CELL CARCINOMA (RCC) POPULATION | Procedure Method Outcomes | Method of monitoring iceball formation=CT | 80 participants |
| RENAL CELL CARCINOMA (RCC) POPULATION | Procedure Method Outcomes | Number of lesions treated with cryoablation is Three | 0 participants |
| RENAL CELL CARCINOMA (RCC) POPULATION | Procedure Method Outcomes | Number of freeze/thaw cycles=3 | 9 participants |
| RENAL CELL CARCINOMA (RCC) POPULATION | Procedure Method Outcomes | Type of hemostatic agents or maneuvers used is None | 85 participants |
| RENAL CELL CARCINOMA (RCC) POPULATION | Procedure Method Outcomes | Method of monitoring iceball formation=Ultrasound | 64 participants |
| RENAL CELL CARCINOMA (RCC) POPULATION | Procedure Method Outcomes | Type of hemostatic agents or maneuvers used=Compression | 3 participants |
| RENAL CELL CARCINOMA (RCC) POPULATION | Procedure Method Outcomes | Complications (malfunction of cryoablation system) | 3 participants |
| RENAL CELL CARCINOMA (RCC) POPULATION | Procedure Method Outcomes | Type of hemostatic agents or maneuvers used=Suturing | 2 participants |
| RENAL CELL CARCINOMA (RCC) POPULATION | Procedure Method Outcomes | Number of freeze/thaw cycles=0* | 1 participants |
| RENAL CELL CARCINOMA (RCC) POPULATION | Procedure Method Outcomes | Type of hemostatic agents or maneuvers used=Floseal | 48 participants |
Secondary
Standard of Care Follow-up Procedures
Characterization of standards of care for cryoablation procedure follow-up across the participating registry centers.
Time frame: These outcomes are measured at each follow-up visit out to 5 years post-cryo procedure
Population: Is participant disease free (renal specific?) Are there new therapies for renal cancer (patient specific)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cryoablation | Standard of Care Follow-up Procedures | Disease free=Indeterminate | 2 participants |
| Cryoablation | Standard of Care Follow-up Procedures | New therapies for renal cancer (patient specific)=Yes [Local] | 4 participants |
| Cryoablation | Standard of Care Follow-up Procedures | Disease free=No | 8 participants |
| Cryoablation | Standard of Care Follow-up Procedures | New therapies for renal cancer (patient specific)=Yes [Systemic] | 0 participants |
| Cryoablation | Standard of Care Follow-up Procedures | New therapies for renal cancer (patient specific)=Yes | 4 participants |
| Cryoablation | Standard of Care Follow-up Procedures | New thereapies for renal cancer (patient specific)=No | 121 participants |
| Cryoablation | Standard of Care Follow-up Procedures | Disease free=Yes | 114 participants |
| RENAL CELL CARCINOMA (RCC) POPULATION | Standard of Care Follow-up Procedures | New thereapies for renal cancer (patient specific)=No | 67 participants |
| RENAL CELL CARCINOMA (RCC) POPULATION | Standard of Care Follow-up Procedures | Disease free=Yes | 61 participants |
| RENAL CELL CARCINOMA (RCC) POPULATION | Standard of Care Follow-up Procedures | Disease free=No | 7 participants |
| RENAL CELL CARCINOMA (RCC) POPULATION | Standard of Care Follow-up Procedures | Disease free=Indeterminate | 2 participants |
| RENAL CELL CARCINOMA (RCC) POPULATION | Standard of Care Follow-up Procedures | New therapies for renal cancer (patient specific)=Yes | 4 participants |
| RENAL CELL CARCINOMA (RCC) POPULATION | Standard of Care Follow-up Procedures | New therapies for renal cancer (patient specific)=Yes [Local] | 4 participants |
| RENAL CELL CARCINOMA (RCC) POPULATION | Standard of Care Follow-up Procedures | New therapies for renal cancer (patient specific)=Yes [Systemic] | 0 participants |