Detecting Bladder Cancer Using the UroMark Test.

NCT02676180 | Completed

• 1 other identifier: 15/0883
• Study Type: observational
• Target: 3,700
• Locations: 1 country
• Sites: 2

Brief Summary

DETECT I is a prospective multicentre observational diagnostic study to assess the performance of the UroMark assay to rule out bladder cancer in patients with haematuria. The study will recruit consecutive patients attending haematuria clinics as well as patients referred to urology outpatient clinics for investigation of haematuria. Consenting patients will be provided with a urine sample collection kit and asked to provide a urine sample. An additional urine sample for control assay testing will be provided after the clinic attendance.

Conditions

Bladder Cancer

Outcome Measures

Primary Outcomes (1)

• Negative predictive value (NPV) of the UroMark test.

  Baseline

Secondary Outcomes (3)

• Negative predictive value (NPV) of control assay (FDA approved urinary marker (UroVision)).

  Baseline

• Negative predictive value (NPV) against imaging (ultrasound/CT)

  Baseline

• Negative predictive value (NPV) against combination of UroMark and imaging.

  Baseline

Interventions

Group OTHER

Also known as: Observational

Eligibility Criteria

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

Study Population

Subjects with visible and non-visible haematuria (blood in urine) will be enrolled. About 10% of cases with haematuria will be found to have bladder cancer. For the majority of cases (60.5%), no cause is found. Other causes include stone disease (3.6%), benign prostate conditions (20-30%), renal disease (9.8%) infection (13%) and renal/prostate cancer (1%). The DETECT I study will determine if the UroMark test can be used to rule out bladder cancer in cases referred for investigation of haematuria.

You may qualify if:

• Participants must be over 18 years of age.
• Participants undergoing investigation for visible and non-visible haematuria.
• Able to give informed written consent.

You may not qualify if:

• Unwilling to have standard haematuria investigations.
• Unable to give informed consent.

Sponsors & Collaborators

• University College, London: lead

Study Sites (2)

UCLH

London, NW1 2BU, United Kingdom

Location

James Cook University Hospital

Middlesbrough, United Kingdom

Location

Related Publications (20)

• Chan AW, Tetzlaff JM, Altman DG, Laupacis A, Gotzsche PC, Krleza-Jeric K, Hrobjartsson A, Mann H, Dickersin K, Berlin JA, Dore CJ, Parulekar WR, Summerskill WS, Groves T, Schulz KF, Sox HC, Rockhold FW, Rennie D, Moher D. SPIRIT 2013 statement: defining standard protocol items for clinical trials. Ann Intern Med. 2013 Feb 5;158(3):200-7. doi: 10.7326/0003-4819-158-3-201302050-00583.

  PMID: 23295957 BACKGROUND

• Chan AW, Tetzlaff JM, Gotzsche PC, Altman DG, Mann H, Berlin JA, Dickersin K, Hrobjartsson A, Schulz KF, Parulekar WR, Krleza-Jeric K, Laupacis A, Moher D. SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials. BMJ. 2013 Jan 8;346:e7586. doi: 10.1136/bmj.e7586.

  PMID: 23303884 BACKGROUND

• Malmstrom PU, Sylvester RJ, Crawford DE, Friedrich M, Krege S, Rintala E, Solsona E, Di Stasi SM, Witjes JA. An individual patient data meta-analysis of the long-term outcome of randomised studies comparing intravesical mitomycin C versus bacillus Calmette-Guerin for non-muscle-invasive bladder cancer. Eur Urol. 2009 Aug;56(2):247-56. doi: 10.1016/j.eururo.2009.04.038. Epub 2009 Apr 24.

  PMID: 19409692 BACKGROUND

• Lyratzopoulos G, Abel GA, McPhail S, Neal RD, Rubin GP. Gender inequalities in the promptness of diagnosis of bladder and renal cancer after symptomatic presentation: evidence from secondary analysis of an English primary care audit survey. BMJ Open. 2013 Jun 24;3(6):e002861. doi: 10.1136/bmjopen-2013-002861.

  PMID: 23798742 BACKGROUND

• Mitra AP, Cote RJ. Molecular screening for bladder cancer: progress and potential. Nat Rev Urol. 2010 Jan;7(1):11-20. doi: 10.1038/nrurol.2009.236.

  PMID: 20062071 BACKGROUND

• Sangar VK, Ragavan N, Matanhelia SS, Watson MW, Blades RA. The economic consequences of prostate and bladder cancer in the UK. BJU Int. 2005 Jan;95(1):59-63. doi: 10.1111/j.1464-410X.2005.05249.x.

  PMID: 15638895 BACKGROUND

• Rodgers M, Nixon J, Hempel S, Aho T, Kelly J, Neal D, Duffy S, Ritchie G, Kleijnen J, Westwood M. Diagnostic tests and algorithms used in the investigation of haematuria: systematic reviews and economic evaluation. Health Technol Assess. 2006 Jun;10(18):iii-iv, xi-259. doi: 10.3310/hta10180.

  PMID: 16729917 BACKGROUND

• Kelly JD, Fawcett DP, Goldberg LC. Assessment and management of non-visible haematuria in primary care. BMJ. 2009 Jan 16;338:a3021. doi: 10.1136/bmj.a3021. No abstract available.

  PMID: 19151065 BACKGROUND

• Mowatt G, N'Dow J, Vale L, Nabi G, Boachie C, Cook JA, Fraser C, Griffiths TR; Aberdeen Technology Assessment Review (TAR) Group. Photodynamic diagnosis of bladder cancer compared with white light cystoscopy: Systematic review and meta-analysis. Int J Technol Assess Health Care. 2011 Jan;27(1):3-10. doi: 10.1017/S0266462310001364. Epub 2011 Jan 25.

  PMID: 21262078 BACKGROUND

• Khadra MH, Pickard RS, Charlton M, Powell PH, Neal DE. A prospective analysis of 1,930 patients with hematuria to evaluate current diagnostic practice. J Urol. 2000 Feb;163(2):524-7.

  PMID: 10647670 BACKGROUND

• Edwards TJ, Dickinson AJ, Natale S, Gosling J, McGrath JS. A prospective analysis of the diagnostic yield resulting from the attendance of 4020 patients at a protocol-driven haematuria clinic. BJU Int. 2006 Feb;97(2):301-5; discussion 305. doi: 10.1111/j.1464-410X.2006.05976.x.

  PMID: 16430634 BACKGROUND

• Lotan Y, Elias K, Svatek RS, Bagrodia A, Nuss G, Moran B, Sagalowsky AI. Bladder cancer screening in a high risk asymptomatic population using a point of care urine based protein tumor marker. J Urol. 2009 Jul;182(1):52-7; discussion 58. doi: 10.1016/j.juro.2009.02.142. Epub 2009 May 17.

  PMID: 19450825 BACKGROUND

• Hoque MO, Begum S, Topaloglu O, Chatterjee A, Rosenbaum E, Van Criekinge W, Westra WH, Schoenberg M, Zahurak M, Goodman SN, Sidransky D. Quantitation of promoter methylation of multiple genes in urine DNA and bladder cancer detection. J Natl Cancer Inst. 2006 Jul 19;98(14):996-1004. doi: 10.1093/jnci/djj265.

  PMID: 16849682 BACKGROUND

• Dudderidge TJ, Kelly JD, Wollenschlaeger A, Okoturo O, Prevost T, Robson W, Leung HY, Williams GH, Stoeber K. Diagnosis of prostate cancer by detection of minichromosome maintenance 5 protein in urine sediments. Br J Cancer. 2010 Aug 24;103(5):701-7. doi: 10.1038/sj.bjc.6605785. Epub 2010 Jul 20.

  PMID: 20648010 BACKGROUND

• Coenen MJ, Ploeg M, Schijvenaars MM, Cornel EB, Karthaus HF, Scheffer H, Witjes JA, Franke B, Kiemeney LA. Allelic imbalance analysis using a single-nucleotide polymorphism microarray for the detection of bladder cancer recurrence. Clin Cancer Res. 2008 Dec 15;14(24):8198-204. doi: 10.1158/1078-0432.CCR-08-1103.

  PMID: 19088036 BACKGROUND

• Tan WS, Ahmad A, Zhou Y, Nathan A, Ogunbo A, Gbolahan O, Kallam N, Smith R, Khalifeh M, Tan WP, Cohen D, Volanis D, Walter FM, Sasieni P, Kamat AM, Kelly JD. Hematuria Cancer Risk Score with Ultrasound Informs Cystoscopy Use in Patients with Hematuria. Eur Urol Oncol. 2025 Feb;8(1):87-93. doi: 10.1016/j.euo.2024.05.005. Epub 2024 May 28.

  PMID: 38811250 DERIVED

• Tan WS, Ahmad A, Feber A, Mostafid H, Cresswell J, Fankhauser CD, Waisbrod S, Hermanns T, Sasieni P, Kelly JD; DETECT I trial collaborators. Development and validation of a haematuria cancer risk score to identify patients at risk of harbouring cancer. J Intern Med. 2019 Apr;285(4):436-445. doi: 10.1111/joim.12868. Epub 2019 Jan 4.

  PMID: 30521125 DERIVED

• Tan WS, Sarpong R, Khetrapal P, Rodney S, Mostafid H, Cresswell J, Watson D, Rane A, Hicks J, Hellawell G, Davies M, Srirangam SJ, Dawson L, Payne D, Williams N, Brew-Graves C, Feber A, Kelly JD; DETECT I trial collaborators. Does urinary cytology have a role in haematuria investigations? BJU Int. 2019 Jan;123(1):74-81. doi: 10.1111/bju.14459. Epub 2018 Aug 29.

  PMID: 30003675 DERIVED

• Tan WS, Feber A, Sarpong R, Khetrapal P, Rodney S, Jalil R, Mostafid H, Cresswell J, Hicks J, Rane A, Henderson A, Watson D, Cherian J, Williams N, Brew-Graves C, Kelly JD; DETECT I trial collaborators. Who Should Be Investigated for Haematuria? Results of a Contemporary Prospective Observational Study of 3556 Patients. Eur Urol. 2018 Jul;74(1):10-14. doi: 10.1016/j.eururo.2018.03.008. Epub 2018 Apr 10.

  PMID: 29653885 DERIVED

• Tan WS, Feber A, Dong L, Sarpong R, Rezaee S, Rodney S, Khetrapal P, de Winter P, Ocampo F, Jalil R, Williams NR, Brew-Graves C, Kelly JD. DETECT I & DETECT II: a study protocol for a prospective multicentre observational study to validate the UroMark assay for the detection of bladder cancer from urinary cells. BMC Cancer. 2017 Nov 15;17(1):767. doi: 10.1186/s12885-017-3758-7.

  PMID: 29141603 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Urine will be collected for analysis using UroMark assay.

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Interventions

Population Groups; Watchful Waiting

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Demography; Population Characteristics; Outcome Assessment, Health Care; Outcome and Process Assessment, Health Care; Quality of Health Care; Health Services Administration

Study Officials

• John Kelly, FRCS (urol)

  UCL

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: CROSS SECTIONAL
• Target Duration: 1 Month
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 18, 2015
• First Posted: February 8, 2016
• Study Start: March 30, 2016
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: December 8, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

GB (2)