Bladder CancerNCT03122964
Multi Institutional Study in Patient Presenting With Hematuria
An observational study of Bladder Cancer and Hematuria, run by MDx Health at 1 site in United States.
Trial summary
The primary objective of this study is to evaluate the performance of the methylation marker panel for the detection of bladder cancer in patients with gross or microscopic hematuria. Read more about this study
- Who is it for?
- Ages 40 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Bladder Cancer, Hematuria
- What is being tested?
- AssureMDx
- How many people
- 1,148 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Mar 2017to 28 Feb 2020
- 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 40 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Subject presents with or has a history of gross hematuria or micro hematuria within the last 3 months
Who may be able to join
- Subject is willing and able to give written informed consent
- Subject presents with or has a history of gross hematuria or microhematuria within the last 3 months
Who cannot join
- Subject has an active urinary tract infection, current urinary retention, active stone disease (renal or bladder), current ureteral stents or nephrostomy tubes, prior bowel interposition, or recent genitourinary instrumentation (within 10 days)
- Subject has a current or past history of genitourinary or urologic cancer within 5 years
- Subject has an active (untreated) cancer of any type, except basal cell skin cancer within 5 years
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Multi Institutional Study To Evaluate Dna Methlyation Markers For Detection Of Primary Bladder Cancer In Urine Samples From A Cohort Of Patients With Hematuria
The primary objective of this study is to evaluate the performance of the methylation marker panel for the detection of bladder cancer in patients with gross or microscopic hematuria.
Read the detailed description
The primary objective of this study is to evaluate the performance of the methylation marker panel for the detection of bladder cancer in patients with gross or microscopic hematuria.
The secondary objective is to evaluate the predictive accuracy of a risk model including clinical factors such as age, gender, smoking history, and presence of gross versus microscopic hematuria compared to a model incorporating the same risk factors along with the methylation marker panel.
- Conditions
- Bladder Cancer, Hematuria
- Being tested
- AssureMDx
- Medical subject headings
- Urinary Bladder Neoplasms, Hematuria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AssureMDxDiagnostic test
combined panel of methylation and mutation markers for the detection of bladder cancer
| Study group | Role | What they receive |
|---|---|---|
| Patients with gross or microscopic hematuria | This study aims to prospectively enroll a minimum of 700 subjects, with gross or microscopic hematuria. Each site will target enrollment of 100 subjects and patient samples will be collected from consecutive patients meeting the inclusion criteria outlined below. The total study duration is expected to be 24 months. Receives: Diagnostic Test: AssureMDx |
What is being measured
The primary outcome is the main question the study is designed to answer.
Performance of a panel of methylation markers for the detection of bladder cancer in patient presenting with hematuria.
Early detection of bladder cancer in patients presenting with hematuria
Measured: 1 year
Secondary outcomes (1)
Predictiveness of a panel of methylation markers combined with clinical risk factors for the detection of bladder cancer.
Accurately predict clinical risk of bladder cancer through clinical factors and methylation markers
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2017
- Study start31 Mar 2017
- Primary completion28 Feb 2020 (estimated)
- Study completion28 Feb 2020 (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
- Case only
- Time perspective
- Prospective
- Enrolment
- 1,148 participants (actual)
Sponsor and investigators
- Lead sponsor
- MDx Health
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03122964
- Sponsor's protocol ID
- Hematuria
- Status last verified
- Mar 2019
- First submitted
- 12 Apr 2017
- Last updated
- 6 Mar 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 6 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi Institutional Study To Evaluate Dna Methlyation Markers For Detection Of Primary Bladder Cancer In Urine Samples From A Cohort Of Patients With Hematuria
- ClinicalTrials.gov ID
- NCT03122964
- Acronym / sponsor ID
- Hematuria
- Conditions
- Bladder Cancer, Hematuria
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,148 participants (actual)
- Lead sponsor
- MDx HealthIndustry (pharma, biotech, devices)
- Study start
- 31 Mar 2017 (actual)
- Primary completion
- 28 Feb 2020 (estimated)
- Study completion
- 28 Feb 2020 (estimated)
- First posted
- 21 Apr 2017 (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.
The primary objective of this study is to evaluate the performance of the methylation marker panel for the detection of bladder cancer in patients with gross or microscopic hematuria.
Detailed description
The primary objective of this study is to evaluate the performance of the methylation marker panel for the detection of bladder cancer in patients with gross or microscopic hematuria.
The secondary objective is to evaluate the predictive accuracy of a risk model including clinical factors such as age, gender, smoking history, and presence of gross versus microscopic hematuria compared to a model incorporating the same risk factors along with the methylation marker panel.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with gross or microscopic hematuria | – | Diagnostic Test: AssureMDxThis study aims to prospectively enroll a minimum of 700 subjects, with gross or microscopic hematuria. Each site will target enrollment of 100 subjects and patient samples will be collected from consecutive patients meeting the inclusion criteria outlined below. The total study duration is expected to be 24 months. |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Subject presents with or has a history of gross hematuria or micro hematuria within the last 3 months
Key inclusion criteria (2 listed)
- Subject is willing and able to give written informed consent
- Subject presents with or has a history of gross hematuria or microhematuria within the last 3 months
Key exclusion criteria (3 listed)
- Subject has an active urinary tract infection, current urinary retention, active stone disease (renal or bladder), current ureteral stents or nephrostomy tubes, prior bowel interposition, or recent genitourinary instrumentation (within 10 days)
- Subject has a current or past history of genitourinary or urologic cancer within 5 years
- Subject has an active (untreated) cancer of any type, except basal cell skin cancer within 5 years
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 |
|---|---|---|
| AssureMDxcombined panel of methylation and mutation markers for the detection of bladder cancer | Diagnostic test | Patients with gross or microscopic hematuria |
Primary outcome
Performance of a panel of methylation markers for the detection of bladder cancer in patient presenting with hematuria.
Time frame: 1 year
Early detection of bladder cancer in patients presenting with hematuria
1 secondary outcome
Predictiveness of a panel of methylation markers combined with clinical risk factors for the detection of bladder cancer.
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2019.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 and Hematuria, run by MDx Health at 1 site in United States.
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 3 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 6 Mar 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 States. 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?
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?
Performance of a panel of methylation markers for the detection of bladder cancer in patient presenting with hematuria. (time frame: 1 year). 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 6 Mar 2019.