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NCT02745301 · ClinicalTrials.gov registry record
Urinary Biomarkers in the Detection of Urothelial Carcinoma of the Bladder
A clinical trial, sponsored by Vanderbilt University.
- Completed
- Registry status
- 50
- Enrollment target
NCT02745301: Completed study, sponsored by Vanderbilt University.
NCT02745301 is a clinical trial that has completed, run by Vanderbilt University. The registered enrollment target is 50 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02745301 has completed, sponsored by Vanderbilt University.
- COMPLETED
- Registry status
- 50 participants
- Enrollment target
Study Summary
To assess the persistence of bladder cancer-specific biomarkers in urine collected pre-operatively, in resected cancer tissue, and in urine collected post-operatively. A panel of sensitive and specific bladder cancer biomarkers will be used to establish a signature of disease in pre-operative patients with a positive diagnosis for bladder cancer by current standard of care (e.g., in-office cystoscopy, OR cystoscopy). The specificity of these markers will be assessed, as well as the degree of non-specific signal attributable to other sources of biomolecules, by analyzing resected tumor tissue for the same biomarkers. Finally, post-operative urine will be assessed for the presence of these markers. To the extent this biomarker panel can be determined to be specific and sensitive, it may serve as an indicator of the degree to which the surgical intervention successfully eradicated the underlying disease. The investigators also aim to assess the stability of a biomarker signature in urine but evaluating several patient specimens over various time points throughout the day.
Primary Outcome
Urinary biomarkers will be assessed pre-operatively from voided specimens. One month post-operatively, voided urine will again be assessed for changes in the level of urinary biomarker. DNA will be isolated from tissue or urine using commercially available validated kits. DNA will be quantified by standard procedures and analyzed for somatic mutation by targeted resequencing of selected regions of the genome. Specific gene targets include TP53, FGFR3, CDKN2A, TERT, and PIK3CA. Hypermethylation a
Interventions
- OTHER Collection of urine and bladder tumor specimens
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2016-04 |
| Est. Completion | 2018-01 |
What the finished NCT02745301 record still lists
NCT02745301 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 50 participants, a relatively small participant target.
The record links to 0 conditions, and to 1 intervention - of which Collection of urine and bladder tumor specimens is the first listed.
NCT02745301 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02745301 about?
NCT02745301 is a clinical study titled "Urinary Biomarkers in the Detection of Urothelial Carcinoma of the Bladder". To assess the persistence of bladder cancer-specific biomarkers in urine collected pre-operatively, in resected cancer tissue, and in urine collected post-operatively. A panel of sensitive and specific bladder cancer biomarkers will be used to establish a signature of disease in pre-operative patien...
What is the current status of trial NCT02745301?
This trial is currently completed. The enrollment target is 50 participants. The study started on 2016-04. Estimated completion is 2018-01.
What interventions are being tested in trial NCT02745301?
The interventions under investigation include: Collection of urine and bladder tumor specimens (OTHER).
Who is sponsoring clinical trial NCT02745301?
This trial is sponsored by Vanderbilt University, which has 430 total clinical trials registered on ClinicalTrials.gov.
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