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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN31161700

Enrollment

Registered

2014-07-25

Start date

2015-04-01

Completion date

Unknown

Last updated

2020-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Topic: Cancer

Interventions

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 tr

Active Surveillance, Participants will be monitored for the duration of the trial

Follow Up Length: 6 month(s)

Study Entry : Single Randomisation only

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Adult diagnosed with renal cancer 20 Hounsfield units.

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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.

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Secondary

Measure	Time frame
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.	—

Measure

Time frame

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.

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Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 8, 2026