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

March 11, 2024 updated by: University of Alberta
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.

Study Overview

Status

Suspended

Conditions

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.

Study Type

Observational

Enrollment (Estimated)

750

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Alberta
      • Calgary, Alberta, Canada
        • University of Calgary
      • Edmonton, Alberta, Canada
        • University of Alberta

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Adult Albertans with a diagnosis of kidney cancer

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
kidney cancer disease-specific survival
Time Frame: 5 years
5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival
Time Frame: 5 years
Overall survival will be calculated in years (Mean and Median will be calculated)
5 years
Glomerular Filtration Rate GFR (mL/min/1.73m2)
Time Frame: 5 years
Renal function measured in Glomerular Filtration Rate GFR (mL/min/1.73m2)
5 years
Serum Creatinine (umol/L)
Time Frame: 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.
5 years
Progression-free survival
Time Frame: 5 years
Local and metastatic disease recurrence measured in years
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Alberta

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2022

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2031

Study Registration Dates

First Submitted

December 13, 2021

First Submitted That Met QC Criteria

January 26, 2022

First Posted (Actual)

January 27, 2022

Study Record Updates

Last Update Posted (Actual)

March 12, 2024

Last Update Submitted That Met QC Criteria

March 11, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HREBA.CC-20-0432

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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