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Study of Minimally-invasive Ablative Renal Therapies (SMART) Registry

Suspended
Conditions
Renal Cancer
Registration Number
NCT05210933
Lead Sponsor
University of Alberta
Brief Summary

Multi-center prospective cohort study examining curative intent renal cryotherapy and radiofrequency ablation for small renal mass treatment in patients who are poor candidates for surgical resection, We will capture clinical, radiological, and pathological data as well as resource utilization (ex: time in hospital, ER visits), complications, and long-term functional and oncological outcomes. The investigators will also be biobanking blood and urine samples from participants for biological studies in the lab.

Detailed Description

Currently the standard-of-care for non-operative renal masses which require treatment is curative ablative therapy. Curative ablative therapies include radiofrequency ablation (RFA) and cryotherapy. A significant number of patients (approximately 40-50%) can only be treated with cryotherapy rather than RFA because of the target lesions close proximity to the collecting system, ureter, solid organs or hollow viscera. Cryotherapy allows for size control of the ablation zone with CT surveillance to avoid iatrogenic injury to these vital structures. On the other hand RFA does not allow for the same ability to control the size of ablation and, unfortunately due to the thermal energy, can result in injury to these structure precluding the use of RFA as a curative therapy for these patients.

Cryoablation of small renal masses provides equivalent intermediate-term cancer control compared to partial nephrectomy. Three-year local recurrence-free survival is 98% for both cryoablation and partial nephrectomy. Similarly metastasis-free survival three years after treatment is 100% for cryoablation and 99% for partial nephrectomy. Curative renal mass ablations provide the added benefit of being outpatient procedures which do not routinely require more than a 4 hour post-procedural recovery and over-the-counter post-procedural analgesic.

Research Question and Objectives:

The objective is to to provide cryotherapy and RFA as curative treatment options for small renal mass treatment in patients who are poor candidates for surgical resection or for those who are not surgical candidates due to co-morbidities. The investigators aim to establish a database that prospectively captures clinical, radiological, and pathological data as well as resource utilization (ex: time in hospital, ER visits), complications, and long-term functional and oncological outcomes. The study will also be biobanking blood and urine samples from participants for biological studies in the lab.

Methods:

Program Design Ablation to be performed percutaneously under CT/ultrasound guidance at the Royal Alexandra Hospital in Edmonton or the Rocky View Health Centre in Calgary, by a team of Interventional Radiologists and Urologists. A CT technologist, Ultrasound technologist and an Interventional Radiologist/Urologist are required for each procedure.

Each patient must have cross sectional imaging (CT or MRI) to confirm that they are a candidate to be treated with curative ablative therapy and to plan the procedure.

Pre-procedural consults by both the Urologist and IR performing the procedure. Patients to be assessed in the diagnostic imaging recovery room (DIRR) prior to the procedure and post-procedure to return to the DIRR or OR recovery room. Procedure to be performed with anesthesia support for deep sedation. Post treatment follow-up will be in accordance with the Canadian Urological Associations published guidelines

Blood and urine samples will be collected at baseline (i.e. study entry), yearly during follow-up for 5 years, and when changes occur in cancer status, for example after radical kidney therapy (surgical removal) or after disease progression (new metastases) during the study's potential observation period.

In addition to the samples, an intake survey must be completed at baseline and ongoing questionnaires completed by participant once a year for five years and when new cancer problems arise until up to five years.

Recruitment & Eligibility

Status
SUSPENDED
Sex
All
Target Recruitment
750
Inclusion Criteria
  • Adults with prior kidney tumor diagnosis;
  • Willing to permit provincial agencies (e.g Alberta Health Services, Alberta Health, Netcare, Service Alberta) to disclose health-related information to study;
  • Canadian and Albertan residents;
  • Signed informed consent.
Exclusion Criteria
  • Unwilling to participate in the study;
  • Unavailable for standard clinical urological care or follow-up in Alberta

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
kidney cancer disease-specific survival5 years
Secondary Outcome Measures
NameTimeMethod
Overall survival5 years

Overall survival will be calculated in years (Mean and Median will be calculated)

Glomerular Filtration Rate GFR (mL/min/1.73m2)5 years

Renal function measured in Glomerular Filtration Rate GFR (mL/min/1.73m2)

Serum Creatinine (umol/L)5 years

Renal function measured in Serum Creatinine (umol/L). Serum Cr will be collected pre-cryotherapy and every 3-6 months following for five years as per Canadian Urological Association Guidelines and our study protocol.

Progression-free survival5 years

Local and metastatic disease recurrence measured in years

Trial Locations

Locations (2)

University of Calgary

🇨🇦

Calgary, Alberta, Canada

University of Alberta

🇨🇦

Edmonton, Alberta, Canada

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