Bladder Cancer Clinical Trial
— DETECT IOfficial 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.
NCT number | NCT02676180 |
Other study ID # | 15/0883 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | March 30, 2016 |
Est. completion date | December 2017 |
Verified date | December 2023 |
Source | University College, London |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational [Patient Registry] |
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.
Status | Completed |
Enrollment | 3700 |
Est. completion date | December 2017 |
Est. primary completion date | December 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Participants must be over 18 years of age. - Participants undergoing investigation for visible and non-visible haematuria. - Able to give informed written consent. Exclusion Criteria: - Unwilling to have standard haematuria investigations. - Unable to give informed consent. |
Country | Name | City | State |
---|---|---|---|
United Kingdom | UCLH | London | |
United Kingdom | James Cook University Hospital | Middlesbrough |
Lead Sponsor | Collaborator |
---|---|
University College, London |
United Kingdom,
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* Note: There are 15 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Negative predictive value (NPV) of the UroMark test. | Baseline | ||
Secondary | Negative predictive value (NPV) of control assay (FDA approved urinary marker (UroVision)). | Baseline | ||
Secondary | Negative predictive value (NPV) against imaging (ultrasound/CT) | Baseline | ||
Secondary | Negative predictive value (NPV) against combination of UroMark and imaging. | Baseline |
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