Urothelial CarcinomaIDENTIFYNCT03548688
Investigation and Detection of Urological Neoplasia in Patients Referred With Suspected Urinary Tract Cancer:
An observational study of Urothelial Carcinoma, run by British Urology Researchers in Surgical Training at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Urothelial Carcinoma
- How many people
- 11,059 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 14 Dec 2017to 1 Jan 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients referred to secondary care for further investigation of suspected urinary tract cancer
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Urothelial Carcinoma
- Keywords
- Bladder Cancer, Haematuria, Collaborative study
- Medical subject headings
- Carcinoma, Transitional Cell, Urinary Bladder Neoplasms, Hematuria
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence
Determine the prevalence of urological cancers in patients presenting to secondary care with suspected urinary tract cancer
Measured: 12 months
Secondary outcomes (4)
Specific prevalence
Determine the difference in prevalence of urological cancer in those undergoing flexible cystoscopy with visible haematuria, non-visible haematuria and without haematuria
Measured: 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.
Measured: 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.
Measured: 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
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2018
- Study start14 Dec 2017
- Primary completion14 Dec 2019
- Study completion1 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urothelial CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 11,059 participants (actual)
Sponsor and investigators
- Lead sponsor
- British Urology Researchers in Surgical Training
- Sponsor type
- University, hospital or other
- Collaborators
- The Urology Foundation, Action Bladder Cancer UK, Test Evaluation Research Group Birmingham University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03548688
- Sponsor's protocol ID
- IDENTIFY
- Other IDs
- ABC UK 2017/18, TUF Grant 2017
- Acronym
- IDENTIFY
- Status last verified
- Nov 2021
- First submitted
- 28 Apr 2018
- Last updated
- 11 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Country specific data to be given to each country
Study at a glance
From the registry record, last updated by the sponsor on 11 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation and Detection of Urological Neoplasia in Patients Referred With Suspected Urinary Tract Cancer: A Multicentre Analysis
- ClinicalTrials.gov ID
- NCT03548688
- Acronym / sponsor ID
- IDENTIFY / IDENTIFY
- Conditions
- Urothelial Carcinoma
- Keywords
- Bladder Cancer, Haematuria, Collaborative study
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 11,059 participants (actual)
- Lead sponsor
- British Urology Researchers in Surgical TrainingUniversity, hospital or other
- Collaborators
- The Urology Foundation, Action Bladder Cancer UK, Test Evaluation Research Group Birmingham University
- Study start
- 14 Dec 2017 (actual)
- Primary completion
- 14 Dec 2019 (actual)
- Study completion
- 1 Jan 2020 (actual)
- First posted
- 7 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients referred to secondary care for further investigation of suspected urinary tract cancer
Key inclusion criteria (2 listed)
- 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)
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Prevalence
Time frame: 12 months
Determine the prevalence of urological cancers in patients presenting to secondary care with suspected urinary tract cancer
4 secondary outcomes
Specific prevalence
Time frame: 12 months
Diagnostic strategies
Time frame: 12 months
Diagnostic performance of imaging
Time frame: 12 months
Associated factors
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Nov 2021.
- Individual participant dataSharing planned: Undecided. Country specific data to be given to each country
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Urothelial Carcinoma, run by British Urology Researchers in Surgical Training at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Nov 2021.