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Recruiting NCT03962920

Personalized Treatment of Urogenital Cancers Depends on the Microbiome

No phase Interventional Microbial Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Tigecycline 50 MG, Placebo.
Who it may be relevant to
Registry conditions: Microbial Disease. Basic parameters: 40 years — 70 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Denmark
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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.

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

Primary outcome measures

  • recurrence rate after surgical treatment of tumour [Time frame: 5 years after treatment]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Denmark · 1 center
  • Zealand University Hospital — Roskilde

Identifiers

NCT: NCT03962920 · ZUHURO

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗