Investigation and Detection of Urological Neoplasia in Patients Referred With Suspected Urinary Tract Cancer: (IDENTIFY)

Investigation and Detection of Urological Neoplasia in Patients Referred With Suspected Urinary Tract Cancer: A Multicentre Analysis

Bladder cancer is common in the UK and can kill. A common sign of bladder cancer is blood in the urine (haematuria).

GPs will refer to a specialist (Urologist) for further investigation of haematuria if they suspect cancer.

Hospitals often have a 'blanket' approach for investigating patients with haematuria. IDENTIFY will collect data on patients having these tests across the UK and internationally, looking at any trends with an aim to create a personalised diagnostic approach for each patient. The data will give patients the ability to make informed decisions, as well as reducing unnecessary and potentially harmful tests.

Study Overview

• Status: Completed
• Conditions: Urothelial Carcinoma

Detailed Description

IDENTIFY aims to be the largest contemporary study providing data on the utility of the current diagnostic pathway for bladder and upper urinary tract cancer in patients presenting with haematuria.

It also aims to provide a contemporary evaluation of current urological practices and assessment of the prevalence of urinary tract cancers (bladder cancer, upper tract cancer, renal cancer) in patients with haematuria. This will allow us to recommend changes in cancer diagnosis pathways that may reduce the number of invasive procedures, reduce waste of resources and optimize use of the most appropriate tests. This will mean resources are spent effectively, allowing for early diagnosis and faster treatment pathways.

An evaluation of the patient factors that predict urinary tract cancer, particularly high-risk disease, may allow clinicians to better recognise groups of patients that will benefit from invasive investigations and are more likely to benefit from prompt diagnosis and treatment. Upper tract urinary cancer is quite rare and difficult to diagnose. It requires a large patient cohort such as the IDENTIFY study in order to recognise associations with the diagnosis of this disease and optimize the way we diagnose it.

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. For example, 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.

IDENTIFY results are also hoped to help inform national and international guidelines on referral for haematuria.

• Study Type: Observational
• Enrollment (Actual): 11059

Contacts and Locations

Study Locations

• United Kingdom
  • London, United Kingdom
    • BURST

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients referred to secondary care for further investigation of suspected urinary tract cancer

Description

Inclusion Criteria:

• Any patient referred with haematuria (visible and non-visible) undergoing cystoscopy
• Any patient referred without haematuria undergoing cystoscopy for the purpose of ruling out urothelial cancer suspected due to other symptoms (e.g. lower urinary tract symptoms, recurrent urinary tract symptoms, dysuria)

Exclusion Criteria:

• Patients with a previous or known diagnosis of primary upper or lower urinary tract urothelial cancers (renal, ureteric, bladder, prostate, urethral and penile cancers)
• Patients with suspected recurrence of upper or lower urinary tract primary urothelial cancer (renal, ureteric, bladder, prostate, urethra and penile cancers)
• Patients undergoing flexible cystoscopy for a reason unrelated to ruling out urinary tract urothelial cancer

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prevalence	Determine the prevalence of urological cancers in patients presenting to secondary care with suspected urinary tract cancer	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Specific prevalence	Determine the difference in prevalence of urological cancer in those undergoing flexible cystoscopy with visible haematuria, non-visible haematuria and without haematuria	12 months
Diagnostic strategies	Describe the current practices in urothelial cancer diagnosis across a range of different healthcare settings in secondary care (district general vs university teaching hospital) with regards to percentage of ultrasound, CT and other imaging modality used for visible and non visible haematuria.	12 months
Diagnostic performance of imaging	Determine the diagnostic performance of US, CT, urine cytology and flexible cystoscopy in patients presenting with haematuria in the diagnosis of bladder cancer, using sensitivity, specificity, positive and negative predictive value.	12 months
Associated factors	Perform a multivariable analysis to determine factors associated with the diagnosis of bladder cancer and upper urinary tract cancer in patients presenting with haematuria	12 months

Collaborators and Investigators

• Sponsor: British Urology Researchers in Surgical Training
• Collaborators: Action Bladder Cancer UK; The Urology Foundation; Test Evaluation Research Group Birmingham University

Study record dates

Study Major Dates

• Study Start (Actual): December 14, 2017
• Primary Completion (Actual): December 14, 2019
• Study Completion (Actual): January 1, 2020

Study Registration Dates

• First Submitted: April 28, 2018
• First Submitted That Met QC Criteria: June 6, 2018
• First Posted (Actual): June 7, 2018

Study Record Updates

• Last Update Posted (Actual): November 11, 2021
• Last Update Submitted That Met QC Criteria: November 9, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Keywords: Bladder Cancer; Collaborative study; Haematuria
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Urologic Neoplasms
• Other Study ID Numbers: IDENTIFY; ABC UK 2017/18 (Other Grant/Funding Number: Action Bladder Cancer UK); TUF Grant 2017 (Other Grant/Funding Number: The Urology Foundation)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Country specific data to be given to each country

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No