Tracking Renal Tumors After Cryoablation Evaluation (TRACE)

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.

Study Overview

• Status: Terminated
• Conditions: Kidney Neoplasms
• Intervention / Treatment: Device: Cryoablation

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 Type: Observational
• Enrollment (Actual): 246

Contacts and Locations

Study Locations

• United States
  • California
    • Orange, California, United States, 92868
      • University of California Irvine
  • Colorado
    • Denver, Colorado, United States, 80205
      • Kaiser Permanente
  • Kentucky
    • Lexington, Kentucky, United States, 40536
      • University of Kentucky
  • Nebraska
    • Omaha, Nebraska, United States, 68198
      • University of Nebraska Medical Center
  • New York
    • New York, New York, United States, 10032
      • Columbia University
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Medical University of South Carolina
  • Tennessee
    • Nashville, Tennessee, United States, 37232
      • Vanderbilt University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Academic medical centers and community-based physicians

Description

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).

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Kidney lesions amenable to cryoablation; Kidney lesions treated with cryoablation.	Device: Cryoablation; Cryoablation (freezing) with Galil Medical cryoablation systems and needles under imaging guidance; Other Names: Visual-ICE cryoablation system; SeedNet cryoablation system; PresIce cryoablation system; IceRod cryoablation needle; IceRod PLUS cryoablation needle; IceRod CX cryoablation needle; IceEDGE 2.4 cryoablation needle; IceSphere cryoablation needle

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Boston Scientific Corporation
• Investigators: Study Chair: Stephen Savage, MD, Medical University of South Carolina; Study Chair: Peter Clark, MD, Wake Forest University Health Sciences

Publications and helpful links

General Publications

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

Study record dates

Study Major Dates

• Study Start (Actual): July 9, 2010
• Primary Completion (Actual): November 24, 2020
• Study Completion (Actual): November 24, 2020

Study Registration Dates

• First Submitted: May 4, 2010
• First Submitted That Met QC Criteria: May 4, 2010
• First Posted (Estimated): May 5, 2010

Study Record Updates

• Last Update Posted (Estimated): January 19, 2024
• Last Update Submitted That Met QC Criteria: April 18, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: cryotherapy; renal cell carcinoma; cryosurgery; kidney tumors; renal tumors; kidney lesions; renal lesions; cryoablation
• Additional Relevant MeSH Terms: Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Kidney Neoplasms
• Other Study ID Numbers: CUC10-RNL02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No