Clinical trial · Observational
Comparative Microbial Analysis of Cystitis in Non-muscle-invasive Bladder Cancer Patients Using Vikor Scientific Urine-ID Testing Menu (IDTM) and Standard Laboratory Culture
Comparative Microbial Analysis of Cystitis in Non-muscle-invasive Bladder Cancer Patients Using Vikor Scientific Urine-IDTM and Standard Laboratory Culture
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Site did not proceed with study.
Summary
Brief summary (as posted)
Vikor Scientific Urine-IDTM is a molecular analysis technology which provides pathogen detection, quantification, and resistance gene identification. Urine-IDTM delivers its results through the technology platform Antibiotic Stewardship program (ABXAssist™), which provides results incorporating regional sensitivity and susceptibility patterns, medication costs, antibiotic spectrum of activity, and FDA guidance. This product aims to deliver prompt, patient-centered and value-based guidance to clinicians for antibiotic selection within 24 hours of delivery to testing facility. 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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Bladder Cancer | Malignant Bladder Neoplasm | CURATED_EXACT | 0.92 |
| Urinary Tract Infections | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Vikor Scientific Urine-IDTM | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (2)
- measure
- To determine if Vikor Scientific Urine-IDTM can identify pathogen (or absence thereof) causing post-TURBT or post-bacillus Calmette Guerin (BCG) cystitis in a timelier manner than standard laboratory culture.
- timeFrame
- 2 years
- measure
- To determine if Vikor Scientific Urine-IDTM provides concordant identification or urinary pathogen and antimicrobial sensitivity compared to standard laboratory culture in post-TURBT or post-BCG cystitis.
- timeFrame
- 2 years
Secondary outcomes (2)
- measure
- To characterize the pathogens involved in post-TURBT and post-BCG Urinary Tract Infection (UTI) and their antibiotic susceptibility/resistance profile
- timeFrame
- 2 years
- measure
- To determine the prevalence of post-TURBT and post-BCG cystitis with no causative pathogenic organism
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Ability of participant OR Legally Authorized Representative (LAR) to understand this study, and participant or LAR willingness to provide informed consent. 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: 1. Inability of participant OR Legally Authorized Representative (LAR) to understand this study, and participant or LAR willingness provide informed consent 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.
References
Publications (0)
Data not yet available