The Investigation and DEtection of urological Neoplasia in paTIents reFerred with suspected urinary tract cancer: A multicentre analYsis (IDENTIFY)
IDENTIFY has stopped recruiting new sites and is in the final period of data collection
IDENTIFY STUDY DEADLINES FOR UK SITES:
30th April 2018: Last day for site registration
1st June 2018: Final entry of new patients having flexible cystoscopy
31st July 2018: Final entry of histopathology and imaging (follow-up) data
IDENTIFY STUDY DEADLINES FOR INTERNATIONAL SITES:
31st Oct 2018: Final entry of new patients having flexible cystoscopy
Clinical practice varies considerably across hospitals and countries for the investigation of patients referred with suspected urinary tract cancer. In the UK, NICE recently set new recommended criteria for suspected cancer referral from primary to secondary care. Furthermore many hospitals have a one-stop clinic where all appropriate investigations may be performed in one visit to screen for urothelial cancer. This will normally include a flexible cystoscopy, but many hospitals will differ in their choice of upper tract imaging as well as the use of other investigations such as urine cytology.
Aims and Objectives
- Determine the prevalence of urological cancers in patients presenting to secondary care with suspected urinary tract cancer (e.g. in patients presenting with haematuria to urology services).
- To determine the difference in diagnostic practice across hospitals and countries and assess if this has an impact on diagnostic yield
- Identify an optimal diagnostic strategy that can be personalised to the individual patient
A multi-centre prospective international service evaluation in at least 5000 patients (largest ever series of this kind), collecting data on patients referred to secondary care with suspected urinary tract cancer, and observing the differences in diagnostic practice between hospitals.
As this is observational only and no there is no intervention the project meets the criteria for a service evaluation project as per the Health Research Authority online tool (see attachment below) and has also been evaluated by the R&D department at Royal Devon and Exeter Hospital. In the UK this means it is exempt from requiring ethics approval.
This service evaluation will be carried out at a number of hospital sites. It is hoped that by observing variation in practice between sites this may help identify areas for service improvement.
Local Hospital Trust data management policies will be followed. Only anonymised data will be collected.
Register your hospital using the link in the registration tab. If your hospital is already registered please email us at firstname.lastname@example.org to add your name to the collaborators there
- Follow @BURSTurology on Twitter for regular updates
Once you have your login details for our online database system (REDCap), start entering data for patients with haematuria (or other presentations) that you investigate at your site
Enter the follow up data on your patients (Imaging/ TURBT/pathology results)
Sept 2017 – Apr 2017: Register centres
- Dec 2017 – Aug 2018: Phase one of data collection – initial phase of data collection including patient demographics, cystoscopy and investigation findings.
- June 2018 – Dec 2018: Phase two of data collection – final investigation results and completion of records.
- Dec 2018 – Feb 2019: Data analysis and results reporting
Benefits of getting involved:
Registration is simple and should avoid formal ethical approvals: In the UK the study will qualify as a “service evaluation” and is exempt from needing ethical approval, although individual centres in other countries will have to follow local governance rules.
Taking part is simple: you will be part of what could potential be the largest prospective study of haematuria investigation ever performed
Anybody who performs investigations on patients referred with haematuria can quickly and easily enter the data into our user-friendly online secure database.
All contributors will receive Pubmed indexed collaborator authorship
The highest recruiting individuals will be invited on the writing committee. The more patients recruited the higher up the collaborative list and you will gain preference for presentation of the study findings at conferences.
Returns on this will be fast
What you will need
Regularly perform, supervise or have access to cystoscopy lists (flexible or rigid) for investigation of haematuria
A consultant/attending who is willing to act as the named supervisor
Each centre will be required to collect data for a minimum of 50 patients.
You are encouraged to work in teams and up to 2 trainees can be recognised as authors for collection of data for these 50 patients.
We will also recognise a supervising consultant on the authorship.
If any additional authors want to take part from the same centre this is still possible.
For each additional trainee author, a further 25 patients will be required per author to gain authorship.
Authors are required to collect data when the patient first presents, when their investigations are complete a few months later and may also be asked to check that their data is accurate towards the end of the study (data validation).
We recognise that some high volume centres will be able to enter data for 50 patients in a few weeks whereas others might take 6 weeks or more. For high-volume centres, we recommend that you collect data for more than 50 patients and will reward centres and individuals who enter data for the most patients across the whole study.
The more patients that a particular author enters data for, the closer to the start of the collaborative authorship list the author will appear. The highest recruiting individuals and centres will also be invited onto the manuscript writing panel and will be given preference to submit and present the work for the whole study at international conferences with an excellent chance of winning prizes.
Key personnel involved in designing the project
This is a BURST-research collaborative led project. This means that the project lead trainee, BURST committee and BURST advisors have worked together to design this project.
- Lead trainee – Mr Sinan Khadhouri
- Key committee members – Mr Matt Jeffries, Mr Taimur Shah, Mr Arjun Nambiar, Mr Kenneth MacKenzie, Mr Kevin Gallagher, Mr Eric Edison, Miss Eleanor Zimmermann, Mr Chuanyu Gao, Ms Lynsey Williams, Mr Sacha Moore.
- Key project supervisors – Mr John McGrath (BAUS Academic Section President, Consultant Urological Surgeon (Royal Devon and Exeter NHS Trust, Honorary Senior Lecturer (University of Exeter Medical School, Cancer Lead – SW NHS Genomic Medicine Centre) & Mr Veeru Kasivisvanathan (BURST Co-chair, NIHR Doctoral Fellow and Urology SpR University College London & UCLH, BAUS Academic Section Committee)
- BURST advisors: Professor Mark Emberton, Professor Hashim Ahmed, Mr Ben Challacombe, Professor Robert Pickard
- IDENTIFY Protocol
- Redcap user guide
- IDENTIFY HRA Decision Tool to confirm no ethics approval required
- IDENTIFY email from research advisor to confirm service evaluation
- Email from Confidentiality Advisory Group (HRA)