SURAB study: comparing ABlation with active SURveillance, in the management of incidentally diagnosed small renal tumours: a feasibility study

Plain English Summary

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

Study website

Type

Scientific

Contact name

Miss Ann Marie Hynes

ORCID ID

Contact details

Clinical Trials Unit
Faculty of Medical Sciences
Newcastle University
1 – 4 Claremont Terrace
Newcastle upon Tyne
NE2 4AE
United Kingdom
+44 (0)191 208 7647
Ann.hynes@newcastle.ac.uk

EudraCT/CTIS number

IRAS number

ClinicalTrials.gov number

Protocol/serial number

17090

Scientific title

SURAB study: a randomised study comparing ABlation with active SURveillance, in the management of incidentally diagnosed small renal tumours: a feasibility study

Acronym

SURAB

Study hypothesis

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

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

Patient information sheet

Not available in web format, please use the contact details to request a patient information sheet

Condition

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

Overall study end date

31/10/2016

Reason abandoned (if study stopped)

Participant 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.

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

Participant 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

Recruitment start date

01/04/2015

Recruitment end date

29/02/2016

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

Organisation

Newcastle upon Tyne Hospitals NHS Foundation (UK)

Sponsor details

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

Sponsor type

Hospital/treatment centre

Website

ROR

https://ror.org/05p40t847

Funder type

Government

Funder name

Health Technology Assessment Programme

Alternative name(s)

NIHR Health Technology Assessment Programme, HTA

Funding Body Type

government organisation

Funding Body Subtype

National government

Location

United Kingdom

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).

Intention to publish date

Individual participant data (IPD) sharing plan

IPD sharing plan summary

Other

Study outputs