Tracking Renal Tumors After Cryoablation Evaluation

Kidney Neoplasms Clinical Trial

— TRACE  

Official title:

Tracking Renal Tumors After Cryoablation Evaluation (TRACE) Registry

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01117779
• Other study ID #: CUC10-RNL02
• Status: Terminated
• Start date: July 9, 2010
• Est. completion date: November 24, 2020

Study information

• Verified date: April 2023
• Source: Boston Scientific Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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 registry. Subjects will be observed for five years from the date of their cryoablation procedure.

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 information / eligibility

• Status: Terminated
• Enrollment: 246
• Est. completion date: November 24, 2020
• Est. primary completion date: November 24, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Kidney Neoplasms

Intervention

Device:
• Cryoablation
Cryoablation (freezing) with Galil Medical cryoablation systems and needles under imaging guidance

Locations

Country	Name	City	State
United States	Medical University of South Carolina	Charleston	South Carolina
United States	Kaiser Permanente	Denver	Colorado
United States	University of Kentucky	Lexington	Kentucky
United States	Vanderbilt University	Nashville	Tennessee
United States	Columbia University	New York	New York
United States	University of Nebraska Medical Center	Omaha	Nebraska
United States	University of California Irvine	Orange	California

Sponsors (1)

Lead Sponsor	Collaborator
Boston Scientific Corporation

Country where clinical trial is conducted

United States, 

References & Publications (6)

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. — View Citation

Goldfarb HA. Nd:YAG laser laparoscopic coagulation of symptomatic myomas. J Reprod Med. 1992 Jul;37(7):636-8. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
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.	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.	Months 6, 12, 24, 36, 48 and 60
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.	Month 60
Primary	Overall Survival Rates	Death due to any cause	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	Months 6 and 12
Primary	Development of Metastatic Disease.	Time between cryotherapy and first evidence of metastatic disease	Month 60
Primary	Total Number of Recurrences	Total recurrences based on imaging with enhancement and retreatments (eg: nephrectomy, partial nephrectomy or ablation).	Month 60
Secondary	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.
Secondary	Standard of Care Follow-up Procedures	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