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

• ClinicalTrials.gov Identifier: NCT03548688
• Recruitment Status: Completed
• First Posted: June 7, 2018
• Last Update Posted: March 13, 2020
• Sponsor: British Urology Researchers in Surgical Training
• Collaborators: The Urology Foundation; Action Bladder Cancer UK; Test Evaluation Research Group Birmingham University
• Information provided by (Responsible Party): British Urology Researchers in Surgical Training

Study Description

Brief Summary:

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.

Condition or disease
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 Design

• Study Type: Observational
• Actual Enrollment: 11059 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Investigation and Detection of Urological Neoplasia in Patients Referred With Suspected Urinary Tract Cancer: A Multicentre Analysis
• Actual Study Start Date: December 14, 2017
• Actual Primary Completion Date: December 14, 2019
• Actual Study Completion Date: January 1, 2020

Groups and Cohorts

Outcome Measures

Primary Outcome Measures :

1. Prevalence [ Time Frame: 12 months ]
   Determine the prevalence of urological cancers in patients presenting to secondary care with suspected urinary tract cancer

Secondary Outcome Measures :

1. Specific prevalence [ Time Frame: 12 months ]
   Determine the difference in prevalence of urological cancer in those undergoing flexible cystoscopy with visible haematuria, non-visible haematuria and without haematuria
2. Diagnostic strategies [ Time Frame: 12 months ]
   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.
3. Diagnostic performance of imaging [ Time Frame: 12 months ]
   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.
4. Associated factors [ Time Frame: 12 months ]
   Perform a multivariable analysis to determine factors associated with the diagnosis of bladder cancer and upper urinary tract cancer in patients presenting with haematuria

Eligibility Criteria

• Ages Eligible for Study: 16 Years and older (Child, Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• Sampling Method: Non-Probability Sample

Study Population

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

Criteria

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

Contacts and Locations

Locations

United Kingdom

BURST

London, United Kingdom

Sponsors and Collaborators

British Urology Researchers in Surgical Training

The Urology Foundation

Action Bladder Cancer UK

Test Evaluation Research Group Birmingham University

More Information

• Responsible Party: British Urology Researchers in Surgical Training
• ClinicalTrials.gov Identifier: NCT03548688
• 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 )
• First Posted: June 7, 2018
• Last Update Posted: March 13, 2020
• Last Verified: March 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided
• Plan Description: Country specific data to be given to each country

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by British Urology Researchers in Surgical Training:

Bladder Cancer; Haematuria; Collaborative study

Additional relevant MeSH terms:

Urologic Neoplasms; Neoplasms; Urogenital Neoplasms; Neoplasms by Site