Comparative Microbial Analysis of Cystitis in Non-muscle-invasive Bladder Cancer Patients Using Vikor Scientific Urine-ID Testing Menu (IDTM) and Standard Laboratory Culture

NCT04583553 | Withdrawn DMC

• 1 other identifier: VS-UrineID
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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

Urinary Tract Infections; Bladder Cancer

Outcome Measures

Primary Outcomes (2)

• 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.

  2 years

• 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.

  2 years

Secondary Outcomes (2)

• To characterize the pathogens involved in post-TURBT and post-BCG Urinary Tract Infection (UTI) and their antibiotic susceptibility/resistance profile

  2 years

• To determine the prevalence of post-TURBT and post-BCG cystitis with no causative pathogenic organism

  2 years

Interventions

Vikor Scientific Urine-IDTM DIAGNOSTIC_TEST

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

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All study participants will be enrolled from KUMC hospital and clinics. A total of 175 participants will be recruited. Participants undergoing the study will be asked to submit urine sample to KUMC Lab within 7 days of onset on cystitis symptoms. Urine sample will be divided for use in standard laboratory culture and Vikor Scientific Urine-IDTM. Urine-IDTM samples will be collected with kits provide by Vikor Scientific. Urine-IDTM kits will be expedited to Vikor Scientific Lab immediately following collection.

You may qualify if:

• Ability of participant OR Legally Authorized Representative (LAR) to understand this study, and participant or LAR willingness to provide informed consent.
• Age ≥ 18 years
• Diagnosis of Non-Muscle Invasive Bladder Cancer (NMIBC)
• Onset of cystitis or UTI symptoms within 7 days of Transurethral Resection of the Bladder Tumor (TURBT) or BCG installation
• Ability to collect urine sample for analysis via standard laboratory culture and Vikor Scientific Urine-IDTM

You may not qualify if:

• Inability of participant OR Legally Authorized Representative (LAR) to understand this study, and participant or LAR willingness provide informed consent
• Age \<18 years
• Diagnosis of Muscle-Invasive or metastatic bladder cancer
• Onset of cystitis greater than 7 days following TURBT or BCG installation
• Inability to provide sufficient urine for both standard laboratory culture and Vikor Scientific Urine-IDTM
• Current prophylactic antibiotic use.

Sponsors & Collaborators

• University of Kansas Medical Center: lead
• Vikor Scientific: collaborator

Study Sites (1)

University of Kansas Medcial Center

Kansas City, Kansas, 66160, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Urine Samples will be collected for study

MeSH Terms

Conditions

Urinary Tract Infections; Urinary Bladder Neoplasms

Condition Hierarchy (Ancestors)

Infections; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Urinary Bladder Diseases

Study Officials

• Eugene Lee, MD

  University of Kansas Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: October 5, 2020
• First Posted: October 12, 2020
• Study Start: December 15, 2021
• Primary Completion: December 30, 2022
• Study Completion: December 30, 2022
• Last Updated: October 15, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)