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 |
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Urothelial Carcinoma |
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 |
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 |
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 |
Inclusion Criteria:
Exclusion Criteria:
United Kingdom | |
BURST | |
London, United Kingdom |
Tracking Information | |||||
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First Submitted Date | April 28, 2018 | ||||
First Posted Date | June 7, 2018 | ||||
Last Update Posted Date | March 13, 2020 | ||||
Actual Study Start Date | December 14, 2017 | ||||
Actual Primary Completion Date | December 14, 2019 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures |
Prevalence [ Time Frame: 12 months ] Determine the prevalence of urological cancers in patients presenting to secondary care with suspected urinary tract cancer
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Original Primary Outcome Measures |
Prevalence [ Time Frame: 12 months ] Determine the prevalence of urological cancers in patients presenting to secondary care with haematuria
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Change History | |||||
Current Secondary Outcome Measures |
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Original Secondary Outcome Measures | Same as current | ||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title | 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 | ||||
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. |
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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. |
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Study Type | Observational | ||||
Study Design | Observational Model: Cohort Time Perspective: Prospective |
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Target Follow-Up Duration | Not Provided | ||||
Biospecimen | Not Provided | ||||
Sampling Method | Non-Probability Sample | ||||
Study Population | Patients referred to secondary care for further investigation of suspected urinary tract cancer | ||||
Condition | Urothelial Carcinoma | ||||
Intervention | Not Provided | ||||
Study Groups/Cohorts | Not Provided | ||||
Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status | Completed | ||||
Actual Enrollment |
11059 | ||||
Original Estimated Enrollment |
5000 | ||||
Actual Study Completion Date | January 1, 2020 | ||||
Actual Primary Completion Date | December 14, 2019 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria |
Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 16 Years and older (Child, Adult, Older Adult) | ||||
Accepts Healthy Volunteers | No | ||||
Contacts | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries | United Kingdom | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number | 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 ) |
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Has Data Monitoring Committee | No | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement |
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Responsible Party | British Urology Researchers in Surgical Training | ||||
Study Sponsor | British Urology Researchers in Surgical Training | ||||
Collaborators |
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Investigators | Not Provided | ||||
PRS Account | British Urology Researchers in Surgical Training | ||||
Verification Date | March 2020 |