Bladder CancerDETECT INCT02676180
Detecting Bladder Cancer Using the UroMark Test.
An observational study of Bladder Cancer, run by University College, London at 2 sites in United Kingdom.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bladder Cancer
- What is being tested?
- Group
- How many people
- 3,700 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- 30 Mar 2016to Dec 2017
- How long will I take part?
- 1 Month
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Participants must be over 18 years of age.
- Participants undergoing investigation for visible and non-visible haematuria.
- Able to give informed written consent.
Who cannot join
- Unwilling to have standard haematuria investigations.
- Unable to give informed consent.
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
UCLH
London, NW1 2BU
James Cook University Hospital
Middlesbrough
About this study
Official title: A Prospective Observational Study to Determine the Negative Predictive Value of UroMark to Rule Out the Presence of Bladder Cancer in Patients With Haematuria.
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.
Read the detailed description
Transitional cell carcinoma (TCC) of the urinary bladder is responsible for >12,000 new cases of cancer and >5,000 deaths per year in England and Wales. Most bladder cancers are non-muscle invasive bladder cancer (NMIBC) and do not invade deeply at presentation, but 80% of tumours recur within 3 years. For muscle invasive bladder cancer (MIBC), the 5 year survival is around 50%. Cystoscopy is the standard test for detection of bladder cancer along with imaging to assess the upper tracts and the common presenting symptom is haematuria. Cystoscopy is an invasive procedure and results in urinary infection in up to 5% of cases. Cystoscopy is performed under local anaesthetic and patients are required to attend hospital clinics for the test. About one in 10 patients who are investigated for haematuria will be found to have bladder cancer. Frequently, patients are not referred for investigation of haematuria at the time of first presentation and there is a delay in diagnosis of the disease. The early detection of bladder cancer by means of a non-invasive tumour marker test would impact on the management of the disease. There is an unmet need for a simple, non-invasive, highly sensitive and specific method for detecting bladder cancer.
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
- Bladder Cancer
- Being tested
- Group
- Medical subject headings
- Urinary Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GroupOther
Also called Observational
What is being measured
The primary outcome is the main question the study is designed to answer.
Negative predictive value (NPV) of the UroMark test.
Measured: Baseline
Secondary outcomes (3)
Negative predictive value (NPV) of control assay (FDA approved urinary marker (UroVision)).
Measured: Baseline
Negative predictive value (NPV) against imaging (ultrasound/CT)
Measured: Baseline
Negative predictive value (NPV) against combination of UroMark and imaging.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2016 (estimated)
- Study start30 Mar 2016
- Primary completionDec 2017
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (20)Papers the sponsor has linked to this study.
- Other trials for Bladder CancerStudies of the same condition, open and under way.
- More trials run by University College, LondonThe sponsor's other registered studies.
- 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
- Case crossover
- Time perspective
- Cross-sectional
- Enrolment
- 3,700 participants (actual)
- Target duration
- 1 Month
Sponsor and investigators
- Lead sponsor
- University College, London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- John Kelly, FRCS (urol), Principal investigator, UCL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02676180
- Sponsor's protocol ID
- 15/0883
- Acronym
- DETECT I
- Status last verified
- Dec 2023
- First submitted
- 18 Dec 2015
- Last updated
- 8 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 23295957Chan 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.
PubMed 23303884Malmstrom 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.
PubMed 19409692Lyratzopoulos 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.
PubMed 23798742Mitra 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.
PubMed 20062071Sangar 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.
PubMed 15638895Rodgers 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.
PubMed 16729917Kelly 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.
PubMed 19151065Mowatt 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.
PubMed 21262078Khadra 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.
PubMed 10647670Edwards 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.
PubMed 16430634Lotan 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.
PubMed 19450825Hoque 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.
PubMed 16849682Dudderidge 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.
PubMed 20648010Coenen 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.
PubMed 19088036
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Observational Study to Determine the Negative Predictive Value of UroMark to Rule Out the Presence of Bladder Cancer in Patients With Haematuria.
- ClinicalTrials.gov ID
- NCT02676180
- Acronym / sponsor ID
- DETECT I / 15/0883
- Conditions
- Bladder Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,700 participants (actual)
- Lead sponsor
- University College, LondonUniversity, hospital or other
- Study start
- 30 Mar 2016 (actual)
- Primary completion
- Dec 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 8 Feb 2016 (estimated)
- 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.
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.
Detailed description
Transitional cell carcinoma (TCC) of the urinary bladder is responsible for >12,000 new cases of cancer and >5,000 deaths per year in England and Wales. Most bladder cancers are non-muscle invasive bladder cancer (NMIBC) and do not invade deeply at presentation, but 80% of tumours recur within 3 years. For muscle invasive bladder cancer (MIBC), the 5 year survival is around 50%. Cystoscopy is the standard test for detection of bladder cancer along with imaging to assess the upper tracts and the common presenting symptom is haematuria. Cystoscopy is an invasive procedure and results in urinary infection in up to 5% of cases. Cystoscopy is performed under local anaesthetic and patients are required to attend hospital clinics for the test. About one in 10 patients who are investigated for haematuria will be found to have bladder cancer. Frequently, patients are not referred for investigation of haematuria at the time of first presentation and there is a delay in diagnosis of the disease. The early detection of bladder cancer by means of a non-invasive tumour marker test would impact on the management of the disease. There is an unmet need for a simple, non-invasive, highly sensitive and specific method for detecting bladder cancer.
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.
Study design
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Month
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- Participants must be over 18 years of age.
- Participants undergoing investigation for visible and non-visible haematuria.
- Able to give informed written consent.
Key exclusion criteria (2 listed)
- Unwilling to have standard haematuria investigations.
- Unable to give informed consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GroupAlso: Observational | Other | – |
Primary outcome
Negative predictive value (NPV) of the UroMark test.
Time frame: Baseline
3 secondary outcomes
Negative predictive value (NPV) of control assay (FDA approved urinary marker (UroVision)).
Time frame: Baseline
Negative predictive value (NPV) against imaging (ultrasound/CT)
Time frame: Baseline
Negative predictive value (NPV) against combination of UroMark and imaging.
Time frame: Baseline
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 8 Dec 2023.
- Background: PubMed 23295957Chan 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.
- Background: PubMed 23303884Chan 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.
- Background: PubMed 19409692Malmstrom 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.
- Background: PubMed 23798742Lyratzopoulos 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.
- Background: PubMed 20062071Mitra 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.
- Background: PubMed 15638895Sangar 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.
- Background: PubMed 16729917Rodgers 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.
- Background: PubMed 19151065Kelly 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.
- Background: PubMed 21262078Mowatt 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.
- Background: PubMed 10647670Khadra 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.
- Background: PubMed 16430634Edwards 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.
- Background: PubMed 19450825Lotan 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.
- Individual participant dataSharing planned: No
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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.
John Kelly, FRCS (urol) principal investigator
UCL
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bladder Cancer, run by University College, London at 2 sites 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 3 inclusion and 2 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 8 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Negative predictive value (NPV) of the UroMark test. (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02676180, which also lists 20 linked publications.
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 8 Dec 2023.