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
Secondary identifying numbers	17090

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

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

http://www.cancerresearchuk.org/about-cancer/find-a-clinical-trial/a-study-looking-at-treatments-for-small-kidney-cancers-surab

Contact information

Miss Ann Marie Hynes
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
Email	Ann.hynes@newcastle.ac.uk

Study information

Study design	Randomised; Interventional; Design type: Process of Care, Treatment
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details to request a patient 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	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.
Secondary outcome measures	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. Outcome data collection in the pilot feasibility trial will be timed to coincide with routine clinical assessments and will collected from patients at 4,7 months post randomisation (3, 6 months post treatment). The following secondary outcome questionnaires will be completed at baseline (within 14 days before randomisation) and at 3 and 6 months post treatment: 1. A general health questionnaire (SF-36) 2. Cancer specific health status and quality of life (FACT-G) 3. Anxiety and depression (STAI) We have also developed and plan to test health economics data collection tools in the form of a participant costs questionnaire (PCQ). The PCQ has two parts: Part A to be administered at 3 month and 6 month and Part B at 6 month only.
Overall study start date	01/10/2014
Completion date	31/10/2016

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	Planned Sample Size: 60; UK Sample Size: 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

England
United Kingdom

Study participating centre

For full details on participating centres please contact:

Clinical Trials Unit
Faculty of Medical Sciences
Newcastle University
1 – 4 Claremont Terrace
Newcastle upon Tyne
NE2 4AE
United Kingdom

Sponsor information

Newcastle upon Tyne Hospitals NHS Foundation (UK)
Hospital/treatment centre

CRO – Level 6; Leazes Wing
Royal Victoria Infirmary
Queen Victoria Road
Newcastle Upon Tyne
NE1 4LP
England
United Kingdom

"ROR"	https://ror.org/05p40t847

Funders

Funder type

Government

Health Technology Assessment Programme
Government organisation / National government

Alternative name(s): NIHR Health Technology Assessment Programme, HTA
Location: United Kingdom

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Other
Publication and dissemination plan	Our exact publication policy is not yet known although conference presentations and a peer-reviewed journal article/s are highly likely. We do not plan to inform patients of results on an individual basis; however, we will aim to disseminate findings to the public (and hence patients) through a range of mechanisms (peer review journal, conference presentations etc).
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/12/2017		Yes	No
Plain English results			09/03/2020	No	Yes
HRA research summary			28/06/2023	No	No

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.