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

Sponsor
University of Alberta (Other)
Overall Status
Recruiting
CT.gov ID
NCT05210933
Collaborator
(none)
750
2
117
375
3.2

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational [Patient Registry]
    Anticipated Enrollment :
    750 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Study of Minimally-invasive Ablative Renal Therapies (SMART) Registry
    Actual Study Start Date :
    Apr 1, 2022
    Anticipated Primary Completion Date :
    Dec 31, 2026
    Anticipated Study Completion Date :
    Dec 31, 2031

    Outcome Measures

    Primary Outcome Measures

    1. kidney cancer disease-specific survival [5 years]

    Secondary Outcome Measures

    1. Overall survival [5 years]

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

    2. Glomerular Filtration Rate GFR (mL/min/1.73m2) [5 years]

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

    3. 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.

    4. Progression-free survival [5 years]

      Local and metastatic disease recurrence measured in years

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Calgary Calgary Alberta Canada
    2 University of Alberta Edmonton Alberta Canada

    Sponsors and Collaborators

    • University of Alberta

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    University of Alberta
    ClinicalTrials.gov Identifier:
    NCT05210933
    Other Study ID Numbers:
    • HREBA.CC-20-0432
    First Posted:
    Jan 27, 2022
    Last Update Posted:
    Apr 7, 2022
    Last Verified:
    Jan 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by University of Alberta
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Apr 7, 2022