CONSERVE study
- Conditions
- Renal CancerKidneyCancerMalignant neoplasm of kidney
- Registration Number
- ISRCTN23852951
- Lead Sponsor
- ewcastle upon Tyne Hospitals NHS Foundation Trust (UK)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 74
1. Age = 18 years
2. ASA physical status classification system of 1 or 2
3. Radiological confirmation of (>20 Hounsfield Unit) enhancing renal mass (< 4cm) or biopsy proven renal cancer
4. CT abdomen/chest/pelvis with no enlarged nodes or distant metastases
5. Patient has provided written informed consent for participation in the study prior to any study specific procedures
6. Target Gender: Male & Female
7. Lower Age Limit 18 years
1. Coagulopathy
2. Concomitant disease that would render the patient unsuitable for the study
3. Presence of urosepsis
4. Cancer which is completely buried in the kidney
5. More than one small renal cancer mass
6. Previous participation in this study
7. Inability to give informed consent; carer/proxy assent will not be allowed in this study
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To estimate the number of patients with a renal mass <4cm who agree to trial randomisation measured at over 18 months of recruitment
- Secondary Outcome Measures
Name Time Method <br> 1. Evaluation of treatment of tumour by CT scan and biopsy measured at using CT scans at 1, 3 and 6 months after treatment and renal biopsy at 6 months<br> 2. Qualitative interview responses for after treatment for patients who are eligible measured at eight to sixteen weeks after treatment<br> 3. Qualitative interview responses for patients who decline randomisation measured at two to sixteen weeks after recruitment interaction<br> 4. Quality of Life questionnaire reporting differences measured within 14 days of randomisation, and at 3 months and 6 months follow-up<br>