Bladder CancerNCT03973307
UroX Biomarker Bladder Cancer Study
An observational study of Bladder Cancer, run by East and North Hertfordshire NHS Trust at 1 site in United Kingdom.
Trial summary
This is a prospective observational study looking at urine samples from participants under referral for a standard of care investigative cystoscopy and biopsy. The study aims to test if the UroX™ biomarker (a measurable indicator of a biological condition) can be detected in urine samples from participants who may… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Bladder Cancer
- What is being tested?
- UroX bladder cancer biomarker test
- How many people
- 100 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 21 Jan 2019to 1 Jul 2025
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Participants under investigation for possible bladder cancer due to undergo cystoscopy and biopsy.
Who may be able to join
- Patients aged ≥ 18 years of age
- Patients under investigation for bladder cancer due to undergo investigative standard of care biopsy
Who cannot join
- Patients aged < 18 years of age
- Patients who are currently undergoing radiation therapy.
- Proposed subject has no bladder (due to surgical removal).
- No cystoscopy and/or pathology information for proposed subject (following cystoscopy for final inclusion in study results)
- Patients unable or unwilling to provide consent
- Patients currently on investigational drug trials
- Patients with Catheter in Situ
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
East and North Hertfordshire NHS Trust
Stevenage, Hertfordshire, SG14AB
Nikhil Vasdev, 01438 28 4042, nikhil.vasdev@nhs.net
About this study
Official title: Evaluation of UroX™ Biomarker Screening Test in the Investigation of Bladder Cancer From Urine Samples - a Single Site Pilot Study
This is a prospective observational study looking at urine samples from participants under referral for a standard of care investigative cystoscopy and biopsy.
The study aims to test if the UroX™ biomarker (a measurable indicator of a biological condition) can be detected in urine samples from participants who may later test positive following a biopsy for bladder cancer. The study aims to assess the value of the biomarker as a screening tool for bladder cancer.
Patients with and those without bladder cancer are required for the study.
Read the detailed description
Patients who undergo investigation for bladder cancer will have a cystoscopy and biopsy as part of their routine care. These patients are then brought back to urology outpatient clinic for their biopsy results within two weeks.
A UroX Biomarker Bladder Cancer Study patient information leaflet will be sent to all patients who are booked for these investigations, explaining the study aims and the requirements for participation.
On the day of their cystoscopy, potential participants will be approached and after signing a study specific consent form, the urine sample will be accepted, given a study number and sent for UroX biomarker testing.
These results will then be returned to the study team for comparison against the biopsy histology result to assess for sensitivity and specificity.
While cystoscopy and biopsy are the current gold standard for diagnosis of bladder cancer, it has been shown to have false-negatives of between 10-40%, due to factors such as operator error or small areas of malignancy(15-17). The possibility of a screening/outpatient test for bladder cancer with high positive predictive value would help with reduction or prioritisation of further investigations and early diagnosis of disease thus potentially allowing alternative treatment options.
- Conditions
- Bladder Cancer
- Being tested
- UroX bladder cancer biomarker test
- 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.
UroX bladder cancer biomarker testDiagnostic test
Urine test using novel UroX biomarker test for bladder malignancy
| Study group | Role | What they receive |
|---|---|---|
| Participants with bladder cancer | 50 participants with histologically confirmed evidence of malignancy for bladder cancer following routine cystoscopy and biopsy. Receives: Diagnostic Test: UroX bladder cancer biomarker test | |
| Participants without bladder cancer | 50 participants with negative biopsy for bladder cancer following routine cystoscopy and biopsy. Receives: Diagnostic Test: UroX bladder cancer biomarker test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the diagnostic accuracy of the UroX™ biomarker urine test
UroX™ urine biomarker staining result compared with standard of care biopsy result
Measured: 1 day (single visit/test)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2019
- Study start21 Jan 2019
- Primary completion1 Jul 2020 (estimated)
- Study completion1 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bladder CancerStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- East and North Hertfordshire NHS Trust
- Sponsor type
- Other government
- Collaborators
- KDx Diagnostics Inc.
- Responsible party
- Sponsor
- Investigators
- Nikhil Vasdev, Principal investigator, East and North Hertfordshire NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03973307
- Sponsor's protocol ID
- RD2018-68
- Status last verified
- Jun 2019
- First submitted
- 1 Jun 2019
- Last updated
- 4 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of UroX™ Biomarker Screening Test in the Investigation of Bladder Cancer From Urine Samples - a Single Site Pilot Study
- ClinicalTrials.gov ID
- NCT03973307
- Acronym / sponsor ID
- RD2018-68
- Conditions
- Bladder Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- East and North Hertfordshire NHS TrustOther government
- Collaborators
- KDx Diagnostics Inc.
- Study start
- 21 Jan 2019 (actual)
- Primary completion
- 1 Jul 2020 (estimated)
- Study completion
- 1 Jul 2025 (estimated)
- First posted
- 4 Jun 2019 (actual)
- 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.
This is a prospective observational study looking at urine samples from participants under referral for a standard of care investigative cystoscopy and biopsy.
The study aims to test if the UroX™ biomarker (a measurable indicator of a biological condition) can be detected in urine samples from participants who may later test positive following a biopsy for bladder cancer. The study aims to assess the value of the biomarker as a screening tool for bladder cancer.
Patients with and those without bladder cancer are required for the study.
Detailed description
Patients who undergo investigation for bladder cancer will have a cystoscopy and biopsy as part of their routine care. These patients are then brought back to urology outpatient clinic for their biopsy results within two weeks.
A UroX Biomarker Bladder Cancer Study patient information leaflet will be sent to all patients who are booked for these investigations, explaining the study aims and the requirements for participation.
On the day of their cystoscopy, potential participants will be approached and after signing a study specific consent form, the urine sample will be accepted, given a study number and sent for UroX biomarker testing.
These results will then be returned to the study team for comparison against the biopsy histology result to assess for sensitivity and specificity.
While cystoscopy and biopsy are the current gold standard for diagnosis of bladder cancer, it has been shown to have false-negatives of between 10-40%, due to factors such as operator error or small areas of malignancy(15-17). The possibility of a screening/outpatient test for bladder cancer with high positive predictive value would help with reduction or prioritisation of further investigations and early diagnosis of disease thus potentially allowing alternative treatment options.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Participants with bladder cancer | – | Diagnostic Test: UroX bladder cancer biomarker test50 participants with histologically confirmed evidence of malignancy for bladder cancer following routine cystoscopy and biopsy. |
| Participants without bladder cancer | – | Diagnostic Test: UroX bladder cancer biomarker test50 participants with negative biopsy for bladder cancer following routine cystoscopy and biopsy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Participants under investigation for possible bladder cancer due to undergo cystoscopy and biopsy.
Key inclusion criteria (2 listed)
- Patients aged ≥ 18 years of age
- Patients under investigation for bladder cancer due to undergo investigative standard of care biopsy
Key exclusion criteria (7 listed)
- Patients aged < 18 years of age
- Patients who are currently undergoing radiation therapy.
- Proposed subject has no bladder (due to surgical removal).
- No cystoscopy and/or pathology information for proposed subject (following cystoscopy for final inclusion in study results)
- Patients unable or unwilling to provide 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 |
|---|---|---|
| UroX bladder cancer biomarker testUrine test using novel UroX biomarker test for bladder malignancy | Diagnostic test | Participants with bladder cancer, Participants without bladder cancer |
Primary outcome
Evaluate the diagnostic accuracy of the UroX™ biomarker urine test
Time frame: 1 day (single visit/test)
UroX™ urine biomarker staining result compared with standard of care biopsy result
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2019.
- Individual participant dataSharing planned: No
Related trials for Bladder Cancer
Recruiting
Role of ERBT Plus Intravesical BCG in Intermediate-Risk or High-Risk NMBC
Bladder Cancer
RecruitingPhase 2
Efficacy and Safety of TYRA-300 in Participants With FGFR3 Altered Low Grade, Intermediate Risk Non-Muscle Invasive Bladder Cancer
Low-grade NMIBC, FGFR Gene Amplification
Active, not recruitingPhase 1/2
Eribulin Mesylate in Treating Patients With Locally Advanced or Metastatic Cancer of the Urothelium and Kidney Dysfunction
Advanced Urothelial Carcinoma, Locally Advanced Urothelial Carcinoma
RecruitingObservational study
The Global En Bloc Resection of Bladder Tumour Registry
Bladder Cancer
RecruitingPhase 2/3
Testing the Role of DNA Released From Tumor Cells Into the Blood in Guiding the Use of Immunotherapy After Surgical Removal of the Bladder, Kidney, Ureter, and Urethra for Urothelial Cancer Treatment, MODERN Study
Muscle Invasive Bladder Urothelial Carcinoma, Muscle Invasive Renal Pelvis Urothelial Carcinoma
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.
Nikhil Vasdev principal investigator
East and North Hertfordshire NHS Trust
1 site 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 East and North Hertfordshire NHS Trust at 1 site 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 2 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 4 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nikhil Vasdev (01438 28 4042, nikhil.vasdev@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate the diagnostic accuracy of the UroX™ biomarker urine test (time frame: 1 day (single visit/test)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Jun 2019.