Kidney NeoplasmsTRACENCT01117779
Tracking Renal Tumors After Cryoablation Evaluation
An observational study of Kidney Neoplasms, run by Boston Scientific Corporation at 7 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Neoplasms
- What is being tested?
- Cryoablation
- Type of treatment
- Medical device
- How many people
- 246 participants
- Where
- 7 sitesUnited States
- Study dates
- 9 Jul 2010to 24 Nov 2020
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Academic medical centers and community-based physicians
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).
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Medical University of South Carolina
Charleston, South Carolina, 29425
Kaiser Permanente
Denver, Colorado, 80205
University of Kentucky
Lexington, Kentucky, 40536
Vanderbilt University
Nashville, Tennessee, 37232
Columbia University
New York, New York, 10032
University of Nebraska Medical Center
Omaha, Nebraska, 68198
University of California Irvine
Orange, California, 92868
About this study
Official title: Tracking Renal Tumors After Cryoablation Evaluation (TRACE) Registry
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.
Read the 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.
- Conditions
- Kidney Neoplasms
- Being tested
- Cryoablation
- Keywords
- kidney tumors, renal tumors, renal cell carcinoma, kidney lesions, renal lesions, cryoablation, cryotherapy, cryosurgery
- Medical subject headings
- Kidney Neoplasms, Carcinoma, Renal Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CryoablationDevice
Also called Visual-ICE cryoablation system, SeedNet cryoablation system, PresIce cryoablation system, IceRod cryoablation needle
Cryoablation (freezing) with Galil Medical cryoablation systems and needles under imaging guidance
| Study group | Role | What they receive |
|---|---|---|
| Kidney lesions amenable to cryoablation | Kidney lesions treated with cryoablation. Receives: Device: Cryoablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Lesion Size
Changes to lesion size using greatest trans-axial diameter (cm) from baseline through the follow-up intervals.
Measured: 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
Measured: 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.
Measured: Average duration of 2 days or longer
Post-cryoablation Lesion Recurrence With Enhancement
Lesions with imaging that showed contrast enhancement based on investigator assessment.
Measured: 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.
Measured: Month 60
Overall Survival Rates
Death due to any cause
Measured: Month 60
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
Measured: Months 6 and 12
Development of Metastatic Disease.
Time between cryotherapy and first evidence of metastatic disease
Measured: Month 60
Total Number of Recurrences
Total recurrences based on imaging with enhancement and retreatments (eg: nephrectomy, partial nephrectomy or ablation).
Measured: Month 60
Secondary outcomes (2)
Procedure Method Outcomes
An assessment of outcomes across laparoscopic-assisted, percutaneous and open cryoablation procedures.
Measured: During the procedure and immediately after it, an average of 2 hours.
Standard of Care Follow-up Procedures
Characterization of standards of care for cryoablation procedure follow-up across the participating registry centers.
Measured: These outcomes are measured at each follow-up visit out to 5 years post-cryo procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2010 (estimated)
- Study start9 Jul 2010
- Primary completion24 Nov 2020
- Study completion24 Nov 2020
Why it stopped: Boston Scientific acquisition of BTG/Galil Medical - business decision made to stop follow-up early
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Kidney NeoplasmsStudies of the same condition, open and under way.
- More trials run by Boston Scientific CorporationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 246 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Scientific Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Stephen Savage, MD, Study chair, Medical University of South CarolinaPeter Clark, MD, Study chair, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01117779
- Sponsor's protocol ID
- CUC10-RNL02
- Acronym
- TRACE
- Status last verified
- Apr 2023
- First submitted
- 4 May 2010
- Last updated
- 19 Jan 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Goldfarb HA. Nd:YAG laser laparoscopic coagulation of symptomatic myomas. J Reprod Med. 1992 Jul;37(7):636-8.
PubMed 1387912Saliken 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.
PubMed 12206845Rewcastle 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.
PubMed 10389867Rewcastle 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.
PubMed 9354166Levey 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.
PubMed 10075613Finley 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.
PubMed 18550087
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tracking Renal Tumors After Cryoablation Evaluation (TRACE) Registry
- ClinicalTrials.gov ID
- NCT01117779
- Acronym / sponsor ID
- TRACE / CUC10-RNL02
- Conditions
- Kidney Neoplasms
- Keywords
- kidney tumors, renal tumors, renal cell carcinoma, kidney lesions, renal lesions, cryoablation, cryotherapy, cryosurgery
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Boston Scientific acquisition of BTG/Galil Medical - business decision made to stop follow-up early
- Enrolment
- 246 participants (actual)
- Lead sponsor
- Boston Scientific CorporationIndustry (pharma, biotech, devices)
- Study start
- 9 Jul 2010 (actual)
- Primary completion
- 24 Nov 2020 (actual)
- Study completion
- 24 Nov 2020 (actual)
- First posted
- 5 May 2010 (estimated)
- Results
- Posted 19 Jan 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Kidney lesions amenable to cryoablation | – | Device: CryoablationKidney lesions treated with cryoablation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Academic medical centers and community-based physicians
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CryoablationAlso: Visual-ICE cryoablation system, SeedNet cryoablation system, PresIce cryoablation system, IceRod cryoablation needleCryoablation (freezing) with Galil Medical cryoablation systems and needles under imaging guidance | Device | Kidney lesions amenable to cryoablation |
Primary outcome
Changes in Lesion Size
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Months 6, 12, 24, 36, 48 and 60
Lesions with imaging that showed contrast enhancement based on investigator assessment.
Disease-specific Survival Rates
Time frame: 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
Time frame: Month 60
Death due to any cause
Quality of Life Assessment
Time frame: 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.
Time frame: Month 60
Time between cryotherapy and first evidence of metastatic disease
Total Number of Recurrences
Time frame: Month 60
Total recurrences based on imaging with enhancement and retreatments (eg: nephrectomy, partial nephrectomy or ablation).
2 secondary outcomes
Procedure Method Outcomes
Time frame: During the procedure and immediately after it, an average of 2 hours.
Standard of Care Follow-up Procedures
Time frame: These outcomes are measured at each follow-up visit out to 5 years post-cryo procedure
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 1387912Goldfarb HA. Nd:YAG laser laparoscopic coagulation of symptomatic myomas. J Reprod Med. 1992 Jul;37(7):636-8.
- Background: PubMed 12206845Saliken 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.
- Background: PubMed 10389867Rewcastle 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.
- Background: PubMed 9354166Rewcastle 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.
- Background: PubMed 10075613Levey 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.
- Background: PubMed 18550087Finley 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephen Savage, MD study chair
Medical University of South Carolina
Peter Clark, MD study chair
Wake Forest University Health Sciences
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Kidney Neoplasms, run by Boston Scientific Corporation at 7 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 19 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Jan 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in Lesion Size (time frame: Baseline and months 6, 12, 24, 36, 48 and 60). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01117779, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jan 2024.