Personalized Treatment of Urogenital Cancers Depends on the Microbiome

Not Applicable

Recruiting

• Conditions: Microbial Disease
• Interventions: Drug: Tigecycline 50 MG; Other: Placebo

• Registration Number: NCT03962920
• Lead Sponsor: Zealand University Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-05-23
• Study First Submitted QC: 2019-05-23
• Study First Posted: 2019-05-24
• Study Start: 2020-05-01
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-28
• Last Update Posted: 2024-01-30
• Primary Completion: 2025-05-01
• Study Completion: 2027-05-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 28

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Surgical treatment + antibiotics	Tigecycline 50 MG	Use antibiotic
surgical treatment + placebo	Placebo	Use placebo

Primary Outcome Measures

Name	Time	Method
recurrence rate after surgical treatment of tumour	5 years after treatment	recurrence rate after surgical treatment of tumour

Trial Locations

Locations (1)

Zealand University Hospital; 🇩🇰 Roskilde, Denmark