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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