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
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

Primary study designInterventional
Study designRandomised; Interventional; Design type: Process of Care, Treatment
Secondary study designRandomised controlled trial
Study type Participant information sheet
Scientific titleSURAB study: a randomised study comparing ABlation with active SURveillance, in the management of incidentally diagnosed small renal tumours: a feasibility study
Study acronymSURAB
Study objectivesThe 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) studiedTopic: Cancer; Subtopic: Renal Cancer; Disease: Kidney
InterventionAblation, 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 typeOther
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.
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.

Completion date31/10/2016

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexAll
Target sample size at registration60
Key inclusion criteria1. 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 criteriaCurrent 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 enrolment01/04/2015
Date of final enrolment29/02/2016

Locations

Countries of recruitment

  • United Kingdom
  • England

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

Results and Publications

Individual participant data (IPD) Intention to shareYes
IPD sharing plan summaryOther
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.