Personalized Treatment of Urogenital Cancers Depends on the Microbiome

Microbial Disease Clinical Trial

Official title:

Personalized Treatment of Urogenital Cancers Depends on the Microbiome

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03962920
• Other study ID #: ZUHURO
• Status: Recruiting
• Phase: N/A
• Start date: May 1, 2020
• Est. completion date: May 1, 2027

Study information

• Verified date: January 2024
• Source: Zealand University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 28
• Est. completion date: May 1, 2027
• Est. primary completion date: May 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Microbial Disease
• Urogenital Neoplasms

Intervention

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

Locations

Country	Name	City	State
Denmark	Zealand University Hospital	Roskilde

Sponsors (1)

Lead Sponsor	Collaborator
Zealand University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	recurrence rate after surgical treatment of tumour	recurrence rate after surgical treatment of tumour	5 years after treatment