Clinical trial NCT03548688: Investigation and Detection of Urological Neoplasia in Patients Referred With Suspected Urinary Tract Cancer:
Official title: Investigation and Detection of Urological Neoplasia in Patients Referred With Suspected Urinary Tract Cancer: A Multicentre Analysis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Urothelial Carcinoma
Keywords: Bladder Cancer
Haematuria
Collaborative study
Lead sponsor: British Urology Researchers in Surgical Training
Sponsor class: OTHER
Collaborators: name: The Urology Foundation
name: Action Bladder Cancer UK
name: Test Evaluation Research Group Birmingham University
First posted: 2018-06-07
Enrollment: 11059
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients referred to secondary care for further investigation of suspected urinary tract cancer

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.

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.

Eligibility 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

Primary outcomes:
measure: Prevalence
timeFrame: 12 months
Secondary outcomes:
measure: Specific prevalence
timeFrame: 12 months
measure: Diagnostic strategies
timeFrame: 12 months
measure: Diagnostic performance of imaging
timeFrame: 12 months
measure: Associated factors
timeFrame: 12 months
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: BURST
Study officials:
References: