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出境医 / 临床实验 / 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: (IDENTIFY)

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
Layout table for study information
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
Arms and Interventions
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
Layout table for eligibility information
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
Layout table for location information
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
Tracking Information
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
 (submitted: March 11, 2020)
Prevalence [ Time Frame: 12 months ]
Determine the prevalence of urological cancers in patients presenting to secondary care with suspected urinary tract cancer
Original Primary Outcome Measures
 (submitted: June 6, 2018)
Prevalence [ Time Frame: 12 months ]
Determine the prevalence of urological cancers in patients presenting to secondary care with haematuria
Change History
Current Secondary Outcome Measures
 (submitted: June 6, 2018)
  • 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
  • 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.
  • 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.
  • 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
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.

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
Study Design Observational Model: Cohort
Time Perspective: Prospective
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.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: March 11, 2020)
11059
Original Estimated Enrollment
 (submitted: June 6, 2018)
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:

  • 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
Sex/Gender
Sexes Eligible for Study: All
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 )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Plan Description: Country specific data to be given to each country
Responsible Party British Urology Researchers in Surgical Training
Study Sponsor British Urology Researchers in Surgical Training
Collaborators
  • The Urology Foundation
  • Action Bladder Cancer UK
  • Test Evaluation Research Group Birmingham University
Investigators Not Provided
PRS Account British Urology Researchers in Surgical Training
Verification Date March 2020

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