Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
3700 participants
OBSERVATIONAL
2016-03-30
2017-12-31
Brief Summary
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Detailed Description
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This study will determine the accuracy of UroMark a high-throughput multiplex PCR test to detect bladder cancer in DNA from urine. The study will address the unmet clinical need to improve detection of bladder cancer. The rationale for the trial is based on proof of concept studies which provide compelling evidence that a panel of methylation markers can be applied to detect bladder cancer with high sensitivity and specificity. It will be also be possible to collect and store fractions of urine for assessment of other DNA related biomarkers as well as non-DNA assays for example cellular proteins, soluble biomarkers in urine supernatant and RNA transcripts in sediment cells. In this study we will compare the UroMark assay with established assays including urinary cytology, FISH as well as developing assays such as MCM5. In this proposal excess urine will be stored for these studies.
Conditions
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Study Design
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CASE_CROSSOVER
CROSS_SECTIONAL
Interventions
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Group
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Participants undergoing investigation for visible and non-visible haematuria.
* Able to give informed written consent.
Exclusion Criteria
* Unable to give informed consent.
18 Years
ALL
No
Sponsors
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University College, London
OTHER
Responsible Party
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Principal Investigators
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John Kelly, FRCS (urol)
Role: PRINCIPAL_INVESTIGATOR
UCL
Locations
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UCLH
London, , United Kingdom
James Cook University Hospital
Middlesbrough, , United Kingdom
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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15/0883
Identifier Type: -
Identifier Source: org_study_id