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Protocol for a feasibility study of a cohort embedded randomised controlled trial comparing NEphron Sparing Treatment
Joana B Neves1,2, David Cullen2, Lee Grant2,3
1Department of Surgical Biotechnology, Division of Surgery and Interventional Science, University College London, London, UK.
Introduction:
Small renal masses (SRMs; ≤4 cm) account for two-thirds of new diagnoses of kidney cancer, the majority of which are incidental findings. The natural history of the SRM seems largely indolent. There is an increasing concern regarding surgical overtreatment and the associated health burden in terms of morbidity and economy. Observational data support the safety and efficacy of percutaneous cryoablation but there is an unmet need for high-quality evidence on non-surgical management options and a head-to-head comparison with standard of care is lacking. Historical interventional trial recruitment difficulties demand novel study conduct approaches. We aim to assess if a novel trial design, the cohort embedded randomised controlled trial (RCT), will enable carrying out such a comparison.
Methods And Analysis:
Single-centre prospective cohort study of adults diagnosed with SRM (n=200) with an open label embedded interventional RCT comparing nephron sparing interventions. Cohort participants will be managed at patient and clinicians' discretion and agree with longitudinal clinical data and biological sample collection, with invitation for trial interventions and participation in comparator control groups. Cohort participants with biopsy-proven renal cell carcinoma eligible for both percutaneous cryoablation and partial nephrectomy will be randomly selected (1:1) and invited to consider percutaneous cryoablation (n=25). The comparator group will be robotic partial nephrectomy (n=25). The primary outcome of this feasibility study is participant recruitment. Qualitative research techniques will assess barriers and recruitment improvement opportunities. Secondary outcomes are participant trial retention, health-related quality of life, treatment complications, blood transfusion rate, intensive care unit admission and renal replacement requirement rates, length of hospital stay, time to return to pre-treatment activities, number of work days lost, and health technologies costs.
Ethics And Dissemination:
Ethical approval has been granted (UK HRA REC 19/EM/0004). Study outputs will be presented and published.
Trial Registration:
ISRCTN18156881; Pre-results.
Insights
This study tests a new trial design to compare cryoablation with robotic partial nephrectomy for small renal masses. The goal is to improve recruitment for kidney cancer clinical trials.
Area of Science:
- Urology
- Oncology
- Clinical Trials
Background:
- Small renal masses (SRMs) represent a significant portion of kidney cancer diagnoses, often found incidentally.
- Concerns exist about overtreatment of largely indolent SRMs, leading to increased morbidity and healthcare costs.
- High-quality evidence comparing non-surgical options like percutaneous cryoablation with standard treatments is lacking.
Purpose of the Study:
- To evaluate a novel cohort-embedded randomized controlled trial (RCT) design for comparing nephron-sparing interventions for SRMs.
- To assess the feasibility of this novel trial design in facilitating head-to-head comparisons.
- To address difficulties in historical interventional trial recruitment.
Main Methods:
- A single-center prospective cohort study (n=200) incorporating an embedded RCT.
- Participants with biopsy-proven renal cell carcinoma eligible for cryoablation or partial nephrectomy will be randomized (1:1) to either intervention (n=25) or robotic partial nephrectomy (n=25).
- Primary outcome is participant recruitment feasibility; secondary outcomes include retention, quality of life, complications, and costs.
Main Results:
- This is a pre-results study; main results are pending.
- Participant recruitment is the primary outcome to assess feasibility.
- Qualitative methods will identify barriers and facilitators to recruitment.
Conclusions:
- This study will determine the feasibility of a novel cohort-embedded RCT design for SRMs.
- Findings will inform future trial conduct for kidney cancer management.
- The study aims to provide better evidence for treatment decisions regarding SRMs.
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