CONSERVE study

ISRCTN	ISRCTN23852951
DOI	https://doi.org/10.1186/ISRCTN23852951
ClinicalTrials.gov number	NCT01608165
Secondary identifying numbers	12184

Submission date: 24/05/2012
Registration date: 24/05/2012
Last edited: 29/03/2022

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Cancer

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

http://cancerhelp.cancerresearchuk.org/trials/a-study-looking-3-different-treatments-for-kidney-cancer-conserve

Contact information

Miss Melinda Jeffels
Scientific

William Leech Building
Framlington Place
Newcastle Upon Tyne
NE2 4HH
United Kingdom

Study information

Study design	Randomised interventional treatment trial
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 below to request a patient information sheet
Scientific title	A feasibility study for a multicentre randomised controlled trial to compare surgery (partial nephrectomy) with needle ablation techniques (radiofrequency ablation/cryotherapy) for the treatment of people with small renal masses (4cm)
Study acronym	CONSERVE
Study objectives	The number of people diagnosed with kidney cancer has doubled over the past 20 years, making it the eight most common cancer in the UK. Most tumours are less than 4cm in size, but over 80% of these are malignant (cancerous) and if left untreated, will slowly grow and spread. Current standard treatment for these small kidney cancers is to remove the diseased part of the kidney in an operation called a partial nephrectomy, but this can be quite a difficult operation. Because of the small tumour size and difficulties with the operation, other treatments have been developed to destroy the tumours. These treatments include radiofrequency ablation, which means that the tumour is destroyed by heat, and cryoablation, which means that the tumour is frozen and destroyed. Although removing the part of the diseased kidney in an operation is the tried and tested way to treat the kidney cancer, it does have risks and complications, such as bleeding. The other two treatments are less intrusive to the patient, and are less complicated as they do not require such a large operation as having part of the kidney removed, but it is not known if they are as good at destroying all of the tumour, and whether or not patients who have their tumour destroyed with these new methods require further treatment in future. In this study, we are trying to determine if a large-scale study comparing these treatments is possible which is why this is called a feasibility study. We are also looking at whether patients would be willing to be randomly assigned to a treatment group. The results of this study will then be compared to see how effective each of the treatments were and whether the number of patients who were happy to be randomly assigned to a treatment could be used to determine the number of patients required in a large-scale trial.
Ethics approval(s)	First MREC 09 May 2012 ref: 12/NE/0147
Health condition(s) or problem(s) studied	Renal Cancer; Kidney
Intervention	Cryoablation, Participants in this study may be randomised to undergo cryoablation as treatment for their small renal mass; Partial Nephrectomy, Participants in this study may be randomised to undergo a partial nephrectomy as treatment for their small renal mass; Radiofrequency ablation, Participants in this study may be randomised to undergo radiofrequency ablation as treatment for their small renal mass; Follow Up Length: 6 month(s)
Intervention type	Other
Primary outcome measure	To estimate the number of patients with a renal mass <4cm who agree to trial randomisation measured at over 18 months of recruitment
Secondary outcome measures	1. Evaluation of treatment of tumour by CT scan and biopsy measured at using CT scans at 1, 3 and 6 months after treatment and renal biopsy at 6 months 2. Qualitative interview responses for after treatment for patients who are eligible measured at eight to sixteen weeks after treatment 3. Qualitative interview responses for patients who decline randomisation measured at two to sixteen weeks after recruitment interaction 4. Quality of Life questionnaire reporting differences measured within 14 days of randomisation, and at 3 months and 6 months follow-up
Overall study start date	15/06/2012
Completion date	15/12/2013

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; Description: As this study is open to competitive recruitment, this breakdown of samples size is an estimation
Total final enrolment	74
Key inclusion criteria	1. Age = 18 years 2. ASA physical status classification system of 1 or 2 3. Radiological confirmation of (>20 Hounsfield Unit) enhancing renal mass (< 4cm) or biopsy proven renal cancer 4. CT abdomen/chest/pelvis with no enlarged nodes or distant metastases 5. Patient has provided written informed consent for participation in the study prior to any study specific procedures 6. Target Gender: Male & Female 7. Lower Age Limit 18 years
Key exclusion criteria	1. Coagulopathy 2. Concomitant disease that would render the patient unsuitable for the study 3. Presence of urosepsis 4. Cancer which is completely buried in the kidney 5. More than one small renal cancer mass 6. Previous participation in this study 7. Inability to give informed consent; carer/proxy assent will not be allowed in this study
Date of first enrolment	15/06/2012
Date of final enrolment	15/12/2013

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

William Leech Building

Newcastle Upon Tyne
NE2 4HH
United Kingdom

Sponsor information

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

Leazes Wing
Royal Victoria Infirmary
Queen Victoria Road
Newcastle Upon Tyne
NE1 4LP
England
United Kingdom

Phone	+44 (0)191 233 6161
Email	webmaster@rmpd.org.uk
Website	http://www.newcastle-hospitals.org.uk/
"ROR"	https://ror.org/05p40t847

Funders

Funder type

Charity

Cancer Research UK
Private sector organisation / Other non-profit organizations

Alternative name(s): CR_UK, Cancer Research UK - London, CRUK
Location: United Kingdom

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan	Not provided at time of registration

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Plain English results		27/06/2016	29/03/2022	No	Yes

Editorial Notes

29/03/2022: The following changes have been made:
1. The Cancer Research UK lay results summary has been added.
2. The total final enrolment number has been added.
13/05/2019: No publications found. All search options exhausted.
15/11/2017: Internal review.
20/04/2016: No publications found, study status unverified.