Comparative Microbial Analysis of Cystitis in Non-muscle-invasive Bladder Cancer Patients Using Vikor Scientific Urine-ID Testing Menu (IDTM) and Standard Laboratory Culture
NCT ID: NCT04583553
Last Updated: 2024-10-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
OBSERVATIONAL
2021-12-15
2022-12-30
Brief Summary
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Proposed advantages of Vikor Scientific Urine-IDTM include:
* Expeditious result (within 24 hours post-lab arrival)
* Simultaneous detection of polymicrobial and monomicrobial infections
* Identification of 49 most common antibiotic resistance genes
* Provision of up-to-date regional sensitivity and susceptibility patterns
* Provision of cost-sensitive treatment options and FDA guidance
* Easy accessibility (mobile, web-portal and electronic health records Integration)
This utility of this technology has yet to be investigated in a clinical study and could prove to be a viable alternative or adjunctive diagnostic tool to standard laboratory culture. Standard laboratory culture can take up to 7 days to return pathogen identification and antibiotic susceptibility, potentially delaying appropriate care and prolonging exposure to inappropriate empiric antibiotics. Our study aims to analyze the ability Vikor Scientific Urine-IDTM to improve time to identification of correct pathogen and accuracy of pathogen identification when compared to standard laboratory culture.
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Detailed Description
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Urine samples will be collected for both standard laboratory culture at KUMC Lab and expedited delivery to Vikor Scientific Lab for Urine-IDTM analysis. Vikor Scientific will cover all costs associated with sample delivery. If insufficient urine volume is collected for both standard laboratory culture at KUMC Lab and Vikor Scientific Urine-IDTM, urine will be preferentially used for standard laboratory culture at KUMC Lab.
Provider clinical decision making will be based on standard laboratory cultures and therapy will not be adjusted based on Vikor Urine-IDTM results.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Interventions
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Vikor Scientific Urine-IDTM
Urine samples will be collected for both standard laboratory culture at KUMC Lab and expedited delivery to Vikor Scientific Lab for Urine-IDTM analysis. Vikor Scientific will cover all costs associated with sample delivery. If insufficient urine volume is collected for both standard laboratory culture at KUMC Lab and Vikor Scientific Urine-IDTM, urine will be preferentially used for standard laboratory culture at KUMC Lab.
Eligibility Criteria
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Inclusion Criteria
2. Age ≥ 18 years
3. Diagnosis of Non-Muscle Invasive Bladder Cancer (NMIBC)
4. Onset of cystitis or UTI symptoms within 7 days of Transurethral Resection of the Bladder Tumor (TURBT) or BCG installation
5. Ability to collect urine sample for analysis via standard laboratory culture and Vikor Scientific Urine-IDTM
Exclusion Criteria
2. Age \<18 years
3. Diagnosis of Muscle-Invasive or metastatic bladder cancer
4. Onset of cystitis greater than 7 days following TURBT or BCG installation
5. Inability to provide sufficient urine for both standard laboratory culture and Vikor Scientific Urine-IDTM
6. Current prophylactic antibiotic use.
18 Years
ALL
No
Sponsors
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Vikor Scientific
UNKNOWN
University of Kansas Medical Center
OTHER
Responsible Party
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Eugene Lee, MD
Associate Professor
Principal Investigators
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Eugene Lee, MD
Role: PRINCIPAL_INVESTIGATOR
University of Kansas Medical Center
Locations
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University of Kansas Medcial Center
Kansas City, Kansas, United States
Countries
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Other Identifiers
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VS-UrineID
Identifier Type: -
Identifier Source: org_study_id
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