[SRPF] – IDENTIFY: The Investigation and Detection of Urological Neoplasia in Patients Referred with Suspected Urinary Tract Cancer: A Multicentre analysis

Veeru Kasivisvanathan and the BURST Collaborative Group wanted to analyse the investigation of blood in pee to improve the personalisation of the testing for urinary tract cancer

Researcher 1 (1)

Veeru Kasivisvanathan’s project aimed to improve the personalisation of testing for bladder cancer.

 

Veeru Kasivisvanathan
Sinan Khadhouri
John McGrath

IDENTIFY: The Investigation and Detection of Urological Neoplasia in Patients Referred with Suspected Urinary Tract Cancer: A Multicentre analysis
Small Research Project – Final report – 8 January 2020

Project start and completion date
Data collection: December 2017 – 2018

Analysis and dissemination: Jan 2019 – Dec 2019

Background and the rationale for the project
A common sign of bladder cancer is blood in the urine (haematuria). GPs will refer to a Urologist for further investigation of haematuria if they suspect cancer. Shared-decision making is extremely important in patients presenting with haematuria and the outcomes of IDENTIFY will allow a more personalized approach to the diagnosis of urinary tract cancer. Rather than a blanket approach in which all patients undergo flexible cystoscopy and one or more imaging tests, we will generate data that could offer patients information on the likelihood of a flexible cystoscopy or other test finding cancer for them, given their personal characteristics, thus creating a personalised diagnostic approach for each patient and reducing unnecessary and potentially harmful tests.

Despite patient and public involvement being critical in the development of novel bladder cancer diagnosis pathways, their involvement is often not made integral to key consultations in pathway development. Patient focus groups throughout the study process will be paramount, as we will require patient support in implementing a practical way to change diagnostic practice and patient-informed decision making.

A key aspect of the data generated from the study is to be able to use it to influence patient pathways and approaches to diagnostic tests in bladder cancer. IDENTIFY results are also hoped to help inform national and international guidelines on referral for haematuria.

The objectives

  1. Establish what current practices are for urinary tract cancer diagnosis in patients presenting with haematuria in the UK and internationally
  2. Give the diagnostic performance of key diagnostic tests (cytology, US, CT, flexible cystoscopy) used in practice
  3. Assess the cost-effectiveness of different diagnostic strategies for patients presenting with haematuria
  4. Identify key patient predictors for diagnosing men with high risk bladder and upper urinary tract cancer
  5. Recommend changes in the diagnostic pathway that will reliably diagnose cancer but cause the least harm to patients, whilst remaining cost-effective

Your study criteria/design for delivering the project

  • This is a prospective multi-centre cohort study
  • It will be carried out in 100 sites, each collecting data for 50 to100 patients depending on centre size

Problems encountered (if any)
Engaging centres in different countries due to different local and national approvals required. However this was overcome and we produced the largest study ever performed in this area (11,000 patients).

Key Findings
Over 11,000 patient records were collected from 110 hospitals in 26 countries (Dec 2017 – Dec 2018). 65.5% had visible haematuria [VH], 28.9% non-visible haematuria [NVH] and 5.6% no haematuria [NH].

The prevalence of bladder cancer [BC] overall was 17.9%; (VH: 22.4%, NVH: 5.2%, NH: 30.6%. The prevalence of Upper tract urothelial cancer [UTUC] was 1.17% (VH: 1.60% NVH: 0.28%), renal cell carcinoma [RCC] 0.98% (VH:1.26% NVH:0.41%) and prostate cancer 1.14% (VH:1.37% NVH:0.54%).

The vast majority of cancers were found in patients referred with VH.

Prevalence varied vastly between hospitals and countries. Prevalence increased with age. No one under the age of 60 with non-visible haematuria had UTUC.

Significance of Findings
Clinicians can counsel patients with these figures as to their personalised risk of having cancer which can influence the diagnostic approach that a particular patient may face. This can aid a shared decision-making approach between patients and clinicians so that appropriate diagnostic tests are chosen leading to optimal cancer detection with minimum patient harm. These figures can influence national and international guideline makers (e.g. NICE, European Association of Urology Guidelines, American Urology Association Guidelines) and clinicians into adopting particular pathways for patients with suspected cancer presenting with different risk factors.

Overview of the project progress
We are very pleased with the outcome of this study. The approach to research and execution of this study is unique. We have received a lot of attention and credit for the work achieved. Through collaboration we have achieved a phenomenal number of patient records and exceeded our expected outcomes well within the timeframe. This is now an exciting time as we begin to influence a safer and more efficient way in utilitsing resources to diagnose bladder cancer and other urinary tract cancers.

Detailed breakdown
1st May 2018 – A breakdown of sites registered and their locations

December 2017 – March 2018: Registration of hospital sites

We managed to advertise and receive interest from 175 hospitals in 33 countries around the world. This was an incredible achievement through the network of registrars, residents and trainees around the world. By the end of the study we had 110 hospitals in 26 countries around the world. A full breakdown of those can be seen in Appendix A.

30th June 2018 – Presentation of project and preliminary site and patient demographics at BAUS Annual conference

IDENTIFY was presented at BAUS 2018 and was very well received. There was a lot of excitement about what a study of this calibre can deliver in terms of changing guidelines and improving healthcare. ABC UK was acknowledged and thanked. The full presentation can be seen at from 15:13 min onwards.

 

31st December 2018 – Data collection complete: aim to collect 5000 patient records

We finished data collection for 11,130 patients in 28 countries around the world. Following data cleaning we had just over 11,000 records in 26 countries. The data was then being sent to our statisticians for the primary analysis. We had also submitted to all major international urological conferences and were accepted to BAUS, EAU, AUA and SIU, as well as many other smaller conferences. A list of conferences and prizes won by the study can be found in Appendix B.

1st April 2019 – quality control and data cleaning complete

We sent the data to the Test Evaluation Research Group in Birmingham with whom we are working closely. They prepared our primary analysis by March in time for the EAU conference. The primary analysis looked at prevalence of cancer in the data set and how it differed in each site and country. We started to explore patterns and look at the reason behind this and learnt how varied the diagnostic practice of haematuria is around the world, and the effect this has on the efficiency of diagnosing cancer.

30th August 2019 – submit work for scientific conferences and prepare paper for publication

As per Appendix B, IDENTIFY has been submitted and presented at many major conferences internationally so that clinicians and patients around the world can benefit from our work. We have written the first paper for publication which is due for submission. In the meantime, further analysis has been performed on risk factors associated with urological cancers and diagnostic test evaluation to make the implications of our work go even futher. The results from these have been submitted to all major international conferences for 2020 (EAU, AUA and BAUS).

Was the project a success? Did you prove what you set out to prove? If not, what do you think the reasons were?
Yes, it was a huge success and we over recruited more than twice what we expected to. It has received much recognition and won awards and prizes.

Potential Clinical Impact – what changes, if any, will you make to patient care or service delivery?
We hope to standardise the type of investigations for patients referred to secondary care with haematuria. This will be done according to the patient’s risks, which will be determined from the study. In doing this we hope to use resources more effectively, reduce unnecessary tests, and reduce costs of haematuria investigation, whilst improving the efficiency of cancer detection.

How will you be disseminating the information gained from your project so that practise can be updated and improved?
See appendix B for list of conferences where results have been disseminated. Furthermore, we will be submitting for publication the main study in a high impact journal.

 

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