Personalized Treatment of Urogenital Cancers Depends on the Microbiome
Overview
This is a randomized controlled trial where patients undergoing surgical treatment for urogenital cancers will be randomized in a two arms study: surgical treatment + antibiotics OR surgical treatment + placebo.
Study Type
- Study Type: Interventional
- Study Design
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Primary Purpose: Treatment
- Masking: Single (Participant)
- Study Primary Completion Date: May 1, 2025
Interventions
- Drug: Tigecycline 50 MG
- Local instillation of drug directly to the tumour tissue
- Other: Placebo
- Local instillation of sterile water directly to the tumour tissue
Arms, Groups and Cohorts
- Active Comparator: Surgical treatment + antibiotics
- Use antibiotic
- Placebo Comparator: surgical treatment + placebo
- Use placebo
Clinical Trial Outcome Measures
Primary Measures
- recurrence rate after surgical treatment of tumour
- Time Frame: 5 years after treatment
- recurrence rate after surgical treatment of tumour
Participating in This Clinical Trial
Inclusion Criteria
- Biopsy verified diagnosis of urological cancer, localized disease Exclusion Criteria:
- Hospitalization within three months of surgery – Antibiotics within three months of surgery – Infectious disease, including UTI's within three months of surgery – History of cancers of the genitourinary tract – Diabetes
Gender Eligibility: All
Minimum Age: 40 Years
Maximum Age: 70 Years
Are Healthy Volunteers Accepted: No
Investigator Details
- Lead Sponsor
- Zealand University Hospital
- Provider of Information About this Clinical Study
- Sponsor
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