SURAB study: comparing ABlation with active SURveillance, in the management of incidentally diagnosed small renal tumours: a feasibility study
| ISRCTN | ISRCTN31161700 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN31161700 |
| Protocol serial number | 17090 |
| Sponsor | Newcastle upon Tyne Hospitals NHS Foundation (UK) |
| Funder | Health Technology Assessment Programme |
- Submission date
- 25/07/2014
- Registration date
- 25/07/2014
- Last edited
- 09/03/2020
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Plain English summary of protocol
Contact information
Scientific
Clinical Trials Unit
Faculty of Medical Sciences
Newcastle University
1 – 4 Claremont Terrace
Newcastle upon Tyne
NE2 4AE
United Kingdom
| Phone | +44 (0)191 208 7647 |
|---|---|
| Ann.hynes@newcastle.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised; Interventional; Design type: Process of Care, Treatment |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | SURAB study: a randomised study comparing ABlation with active SURveillance, in the management of incidentally diagnosed small renal tumours: a feasibility study |
| Study acronym | SURAB |
| Study objectives | The aim of this study is to establish whether a future definitive trial comparing active surveillance with ablative treatment for small kidney cancer is feasible. There is also a pre-pilot qualitative component to the study which will inform trial design. More details can be found at http://www.nets.nihr.ac.uk/projects/hta/1110701 Protocol can be found at http://www.nets.nihr.ac.uk/__data/assets/pdf_file/0018/115560/PRO-11-107-01.pdf |
| Ethics approval(s) | 14/NE/0155; First MREC approval date 26/07/2014 |
| Health condition(s) or problem(s) studied | Topic: Cancer; Subtopic: Renal Cancer; Disease: Kidney |
| Intervention | Ablation, Currently, centres have tended to develop expertise in either cryotherapy or radiofrequency ablation; centres will therefore offer only one form of ablation (the one in which they have expertise). There will also be an opportunity for departments which offer microwave ablation to participate in the trial.; Active Surveillance, Participants will be monitored for the duration of the trial; Follow Up Length: 6 month(s); Study Entry : Single Randomisation only |
| Intervention type | Other |
| Primary outcome measure(s) |
The aim is to establish whether a future definitive trial comparing active surveillance with ablative treatment for small kidney cancer is feasible. This will be assessed quantitatively in terms of recruitment and retention rates and qualitatively in terms of the patients' experiences and understanding of the randomisation process and treatment options. Partition of reasons for loss to follow up, together with clinical data, will allow us to project likely retention at 5 years. |
| Key secondary outcome measure(s) |
All secondary outcomes will be rehearsed during the pilot trial with a view to refining the choice of outcomes for the main trial, based on data yield and quality. |
| Completion date | 31/10/2016 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 60 |
| Key inclusion criteria | 1. Adult diagnosed with renal cancer < 4 cm (confirmation by radiology* or by biopsy) 2. ASA physical status classification system grade 1 or 2 3. Age =18 years of age 4. CT/MRI abdomen/chest with no evidence of metastases 5. Patient has provided written informed consent prior to any study specific procedures *Radiological confirmation requires noting an enhancing renal mass of >20 Hounsfield units. |
| Key exclusion criteria | Current exclusion criteria as of 09/03/2015: Patients the clinician does not feel would be suitable for the trial (e.g., due to concomitant disease) 1. Multiple small renal cancers in one kidney 2. Coagulopathy that cannot be corrected 3. Previous participation in this study 4. Inability to give informed consent; carer/proxy consent will not be allowed in this study Previous exclusion criteria: Patients the clinician does not feel would be suitable for the trial (e.g., due to concomitant disease) 1. Fuhrman grade 3 / 4 2. Multiple small renal cancers in one kidney 3. Coagulopathy that cannot be corrected 4. Previous participation in this study 5. Inability to give informed consent; carer/proxy consent will not be allowed in this study |
| Date of first enrolment | 01/04/2015 |
| Date of final enrolment | 29/02/2016 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Faculty of Medical Sciences
Newcastle University
1 – 4 Claremont Terrace
Newcastle upon Tyne
NE2 4AE
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Other |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/12/2017 | Yes | No | |
| HRA research summary | 28/06/2023 | No | No | ||
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
| Plain English results | 09/03/2020 | No | Yes |
Editorial Notes
09/03/2020: Link added to results (plain English)
14/02/2018: Publication reference added.
09/03/2015: The overall trial end date was changed from 21/10/2015 to 31/10/2016.