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| Name | Class |
|---|---|
| Cytosystems Ltd | UNKNOWN |
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Is BladderLight® (BL) urine testing accurate, as a non-invasive method, to exclude presence of bladder cancer in patients.
There are three arms to the proposed performance evaluation of the integrated test - arms 1 and 2 are cross-sectional studies examining the accuracy of the BladderLight® test in the detection of cancer of the urinary bladder in patients attending either Gross Haematuria clinic for a potential primary (first time) diagnosis (arm 1) or patients attending Cystsoscopic Surveillance clinic as follow up to a previous, treated case of bladder cancer (arm 2). Arm 3 is a longitudinal examination of disease state following a negative cystoscopy with a positive BladderLight® test - this will examine whether BladderLight® can predict progression to overt disease. Arm three will not involve any further requirement for physical sampling, but will involve result checking on subsequent cystoscopies
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cystoscopic surveillance | Experimental | Patients with previous history of bladder cancer undergoing flexible cystoscopy will privide a urine sample to see if BladderLight system can exclude presence of bladder cancer |
|
| Haematuria group | Experimental | Patients referred with haematuria to exclude bladder cancer will privide a urine sample to see if BladderLight system can exclude presence of bladder cancer |
|
| Longitudinal group | No Intervention | Patient with Negative cystoscopy with a positive BladderLight® test will be followed for 12 months to see if they subsequently develop bladder cancer. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BladderLight® | Device | Using a cell collection device to look for the presence of bladder cancer cells |
|
| Measure | Description | Time Frame |
|---|---|---|
| To exclude presence of bladder cancer with sensitivity of 85% | In each cohort of the study sensitivity, specificity, negative and positive predictive value for detection of cancer will be calculated. | 12 month |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| kasra Paeb-Parsy, MBBS, FRCSEd | Contact | +44(0)7769714323 | kasra.saeb-parsy@nhs.net |
| Name | Affiliation | Role |
|---|---|---|
| kasra Saeb-Parsy, MBBS, FRCSEd | Cambridge University Hospitals NHS Foundation Trust | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22968648 | Background | Saeb-Parsy K, Wilson A, Scarpini C, Corcoran M, Chilcott S, McKean M, Thottakam B, Rai B, Nabi G, Rana D, Perera M, Stewart K, Laskey RA, Neal DE, Coleman N. Diagnosis of bladder cancer by immunocytochemical detection of minichromosome maintenance protein-2 in cells retrieved from urine. Br J Cancer. 2012 Oct 9;107(8):1384-91. doi: 10.1038/bjc.2012.381. Epub 2012 Sep 11. |
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Data will be published in peer reviewed journals and presented at scientific meetings
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| ID | Term |
|---|---|
| D001749 | Urinary Bladder Neoplasms |
| D006417 | Hematuria |
| D012008 | Recurrence |
| ID | Term |
|---|---|
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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all eligible patients will be recruited
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| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
| D014555 | Urination Disorders |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D020969 | Disease Attributes |