Personalized Treatment of Urogenital Cancers Depends on the Microbiome

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.

Recruiting

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Key information

Conditions

Microbial Disease

Age range

40 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Zealand University Hospital

Roskilde, 4000, Denmark

Location status: Recruiting

Location contact

Nessn Azawi, M.D.

PRINCIPAL_INVESTIGATOR

Nessn H. Azawi, M.D.

CONTACT

[email protected]

004526393034

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tigecycline 50 MG

Drug

Local instillation of drug directly to the tumour tissue

Other names: Tigecycline

Placebo

Other

Local instillation of sterile water directly to the tumour tissue

Other names: Sterile water

Primary outcomes

recurrence rate after surgical treatment of tumour

Time frame: 5 years after treatment

recurrence rate after surgical treatment of tumour

Sponsors and collaborators

Lead sponsor

Zealand University Hospital

Other

Registry information

Important dates

Study start: 2020
Primary completion: 2025
Study completion: 2027
First posted: May 24, 2019
Registry last updated: Jan 30, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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