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

NCT03548688 | Completed

• 3 other identifiers: IDENTIFYABC UK 2017/18TUF Grant 2017
• Study Type: observational
• Target: 11,059
• Locations: 1 country
• Sites: 1

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.

Conditions

Urothelial Carcinoma

Keywords

Bladder Cancer; Haematuria; Collaborative study

Outcome Measures

Primary Outcomes (1)

• Prevalence

  Determine the prevalence of urological cancers in patients presenting to secondary care with suspected urinary tract cancer

  12 months

Secondary Outcomes (4)

• Specific prevalence

  12 months

• Diagnostic strategies

  12 months

• Diagnostic performance of imaging

  12 months

• Associated factors

  12 months

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• British Urology Researchers in Surgical Training: lead
• The Urology Foundation: collaborator
• Action Bladder Cancer UK: collaborator
• Test Evaluation Research Group Birmingham University: collaborator

Study Sites (1)

BURST

London, United Kingdom

Location

MeSH Terms

Conditions

Carcinoma, Transitional Cell; Urinary Bladder Neoplasms; Hematuria

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases; Urination Disorders; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 28, 2018
• First Posted: June 7, 2018
• Study Start: December 14, 2017
• Primary Completion: December 14, 2019
• Study Completion: January 1, 2020
• Last Updated: November 11, 2021

Record last verified: 2021-11

Locations

GB (1)