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Boston Scientific acquisition of BTG/Galil Medical - business decision made to stop follow-up early
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Kidney lesions amenable to cryoablation | Kidney lesions treated with cryoablation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cryoablation | Device | Cryoablation (freezing) with Galil Medical cryoablation systems and needles under imaging guidance |
|
| Measure | Description | Time Frame |
|---|---|---|
| Changes in Lesion Size | Changes to lesion size using greatest trans-axial diameter (cm) from baseline through the follow-up intervals. | Baseline and months 6, 12, 24, 36, 48 and 60 |
| Renal Function Status | Determined by the estimated Median Glomerular Filtration Rate (eGFR) measure using mL/min | Baseline and months 6, 12, 24, 36, 48 and 60 |
| 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. | Average duration of 2 days or longer |
| Post-cryoablation Lesion Recurrence With Enhancement | Lesions with imaging that showed contrast enhancement based on investigator assessment. | Months 6, 12, 24, 36, 48 and 60 |
| 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. | Month 60 |
| Overall Survival Rates | Death due to any cause | Month 60 |
| Quality of Life Assessment |
| Measure | Description | Time Frame |
|---|---|---|
| Procedure Method Outcomes | An assessment of outcomes across laparoscopic-assisted, percutaneous and open cryoablation procedures. | During the procedure and immediately after it, an average of 2 hours. |
| Standard of Care Follow-up Procedures |
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Suggested Inclusion Criteria:
Suggested Exclusion Criteria:
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Academic medical centers and community-based physicians
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| Name | Affiliation | Role |
|---|---|---|
| Stephen Savage, MD | Medical University of South Carolina | Study Chair |
| Peter Clark, MD | Wake Forest University Health Sciences | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California Irvine | Orange | California | 92868 | United States | ||
| Kaiser Permanente |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 1387912 | Background | Goldfarb HA. Nd:YAG laser laparoscopic coagulation of symptomatic myomas. J Reprod Med. 1992 Jul;37(7):636-8. | |
| 12206845 | Background | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Cryoablation | Cryoablation: Cryoablation (freezing) with Galil Medical cryoablation systems and needles under imaging guidance There were a total of 246 ITT participants out of that 145 participants had lesion biopsy with proven Renal Cell Carcinoma (RCC). |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Changes in Lesion Size | Changes to lesion size using greatest trans-axial diameter (cm) from baseline through the follow-up intervals. | Participants for whom cryoablation via GALIL Medical Cryoablation system was performed with available data at the respective time point. | Posted | Median | Inter-Quartile Range | cm | Baseline and months 6, 12, 24, 36, 48 and 60 | lesions | lesions |
|
Median follow-up of 60.1 months
Potentially and directly related cryoablation AEs, SAEs/UADEs
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Kidney Lesions Amenable to Cryoablation [ITT Population] | 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 patients with 145 patients having lesions biopsied and proven Renal Cell Carcinoma (RCC). |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| BLEEDING/HEMORRHAGE, GU | Surgical and medical procedures | CTCAE (3.0) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| OTHER | General disorders | CTCAE (3.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chantal Laframboise, Clinical Research Manager | Boston Scientific | 613-882-0876 | chantal.laframboise@bsci.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 20, 2011 | Nov 17, 2021 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 21, 2018 | Nov 17, 2021 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D007680 | Kidney Neoplasms |
| D002292 | Carcinoma, Renal Cell |
| ID | Term |
|---|---|
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D003452 | Cryosurgery |
| ID | Term |
|---|---|
| D055011 | Ablation Techniques |
| D013514 | Surgical Procedures, Operative |
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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
| Months 6 and 12 |
| Development of Metastatic Disease. | Time between cryotherapy and first evidence of metastatic disease | Month 60 |
| Total Number of Recurrences | Total recurrences based on imaging with enhancement and retreatments (eg: nephrectomy, partial nephrectomy or ablation). | Month 60 |
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 |
| Denver |
| Colorado |
| 80205 |
| United States |
| University of Kentucky | Lexington | Kentucky | 40536 | United States |
| University of Nebraska Medical Center | Omaha | Nebraska | 68198 | United States |
| Columbia University | New York | New York | 10032 | United States |
| Medical University of South Carolina | Charleston | South Carolina | 29425 | United States |
| Vanderbilt University | Nashville | Tennessee | 37232 | United States |
| 10389867 | Background | 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. |
| 9354166 | Background | 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. |
| 10075613 | Background | 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. |
| 18550087 | Background | 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. |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Lesion Size | Lesion size measured by greatest trans-axial diameter (cm) | Median | Inter-Quartile Range | cm |
|
| Quality of Life (QOL) Over time as assessed by the Short Form-12 (SF-12) GM | 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 | Median | Full Range | score on a scale |
|
| Units | Counts |
|---|
| Participants |
|
| lesions |
|
|
| Primary | Renal Function Status | Determined by the estimated Median Glomerular Filtration Rate (eGFR) measure using mL/min | Posted | Median | Inter-Quartile Range | ml/min | Baseline and months 6, 12, 24, 36, 48 and 60 |
|
|
|
| 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. | Posted | Median | Inter-Quartile Range | hours | Average duration of 2 days or longer |
|
|
|
| Primary | Post-cryoablation Lesion Recurrence With Enhancement | Lesions with imaging that showed contrast enhancement based on investigator assessment. | Lesion recurrence with enhancement | Posted | Count of Units | lesions | Months 6, 12, 24, 36, 48 and 60 | lesions | lesions |
|
|
|
| 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. | Posted | Count of Participants | Participants | Month 60 |
|
|
|
| Primary | Overall Survival Rates | Death due to any cause | Posted | Count of Participants | Participants | Month 60 |
|
|
|
| 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 | Posted | Median | Full Range | score on a scale | Months 6 and 12 |
|
|
|
| Primary | Development of Metastatic Disease. | Time between cryotherapy and first evidence of metastatic disease | Posted | Median | Inter-Quartile Range | months | Month 60 |
|
|
|
| Primary | Total Number of Recurrences | Total recurrences based on imaging with enhancement and retreatments (eg: nephrectomy, partial nephrectomy or ablation). | Posted | Number | recurrence | Month 60 |
|
|
|
| Secondary | Procedure Method Outcomes | An assessment of outcomes across laparoscopic-assisted, percutaneous and open cryoablation procedures. | Participants treated with laparoscopic, percutaneous, or open procedure. | Posted | Number | participants | During the procedure and immediately after it, an average of 2 hours. |
|
|
|
| Secondary | Standard of Care Follow-up Procedures | Characterization of standards of care for cryoablation procedure follow-up across the participating registry centers. | Is participant disease free (renal specific?) Are there new therapies for renal cancer (patient specific) | Posted | Number | participants | These outcomes are measured at each follow-up visit out to 5 years post-cryo procedure |
|
|
|
| 26 |
| 246 |
| 11 |
| 246 |
| 33 |
| 246 |
| ARRHYTHMIA-SUPRAVENTRICULAR | Cardiac disorders | CTCAE (3.0) | Systematic Assessment |
|
| HEMATOMA | Surgical and medical procedures | CTCAE (3.0) | Systematic Assessment |
|
| INFECTION (DOCUMENTED CLINICALLY) WITH GRADE 3 OR 4 ANC | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| PAIN | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| PLEURAL EFFUSION (NON-MALIGNANT) | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| RENAL HEMORRHAGE | Renal and urinary disorders | CTCAE (3.0) | Systematic Assessment |
|
| STRICTURE OF THE COLLECTION SYSTEM OR URETERS/STRICTURE/STENOSIS | Renal and urinary disorders | CTCAE (3.0) | Systematic Assessment |
|
| OTHER | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| PAIN | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| HEMATOMA | Surgical and medical procedures | CTCAE (3.0) | Systematic Assessment |
|
| CREATININE ELEVATION | Renal and urinary disorders | CTCAE (3.0) | Systematic Assessment |
|
| URINARY RETENTION/OLIGURIA | Renal and urinary disorders | CTCAE (3.0) | Systematic Assessment |
|
| BLEEDING/HEMORRHAGE, GU | Renal and urinary disorders | CTCAE (3.0) | Systematic Assessment |
|
| VOMITING | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| ARRHYTHMIA-SUPRAVENTRICULAR | Cardiac disorders | CTCAE (3.0) | Systematic Assessment |
|
| ATELECTASIS | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| BLEEDING/HEMORRHAGE, GI | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| HYPERTENSION | Vascular disorders | CTCAE (3.0) | Systematic Assessment |
|
| PNEUMOTHORAX | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| RENAL HEMORRHAGE | Renal and urinary disorders | CTCAE (3.0) | Systematic Assessment |
|
Per the Boston Scientific (BSCI) Clinical Trial Agreement, BSCI needs to publish first.
PIs may publish their own data one year after the study has completed. If the PI wishes to publish after BSCI, then BSCI needs to be acknowledged in the publication.
| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
|
| Month 24 |
|
| Month 36 |
|
| Month 48 |
|
| Month 60 |
|
| Title | Measurements |
|---|
|
| Month 36 |
|
| Month 48 |
|
| Month 60 |
|
|
| Physical Functioning at month 12 |
|
| Role Physical at month 6 |
|
| Role Physical at month 12 |
|
| Bodily Pain at month 6 |
|
| Bodily Pain at month 12 |
|
| Vitality at month 6 |
|
| Vitality at month 12 |
|
| Social Functioning at month 6 |
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| Social Functioning at month 12 |
|
| Mental Health at month 6 |
|
| Mental Health at month 12 |
|
| Role Emotional at month 6 |
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| Role Emotional at month 12 |
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| Physical Component Summary at month 6 |
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| Physical Component Summary at month 12 |
|
| Mental Component summary at month 6 |
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| Mental Component summary at month 12 |
|
| Procedure Method: Open |
|
| Number of lesions treated with cryoablation is One |
|
| Number of lesions treated with cryoablation is Two |
|
| Number of lesions treated with cryoablation is Three |
|
| Type of hemostatic agents or maneuvers used is None |
|
| Type of hemostatic agents or maneuvers used=Compression |
|
| Type of hemostatic agents or maneuvers used=Suturing |
|
| Type of hemostatic agents or maneuvers used=Floseal |
|
| Type of hemostatic agens or maneuvers used=Surgical |
|
| Type of hemostatic agents or maneuversed used=Other |
|
| Method of monitoring iceball formation=CT |
|
| Method of monitoring iceball formation=Ultrasound |
|
| Number of freeze/thaw cycles=0* |
|
| Number of freeze/thaw cycles=2 |
|
| Number of freeze/thaw cycles=3 |
|
| Number of freeze/thaw cycles=4 |
|
| Complications (malfunction of cryoablation system) |
|
| Intra-operative patient complications |
|
| Disease free=Indeterminate |
|
| New therapies for renal cancer (patient specific)=Yes |
|
| New therapies for renal cancer (patient specific)=Yes [Local] |
|
| New therapies for renal cancer (patient specific)=Yes [Systemic] |
|
| New thereapies for renal cancer (patient specific)=No |
|