Personalized Treatment of Urogenital Cancers Depends on the Microbiome

January 28, 2024 updated by: Zealand University Hospital
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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

28

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Roskilde, Denmark, 4000
        • Recruiting
        • Zealand University Hospital
        • Contact:
        • Principal Investigator:
          • Nessn Azawi, M.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Surgical treatment + antibiotics
Use antibiotic
Drug: Tigecycline 50 MG
Local instillation of drug directly to the tumour tissue
Other Names:
  • Tigecycline
Placebo Comparator: surgical treatment + placebo
Use placebo
Other: Placebo
Local instillation of sterile water directly to the tumour tissue
Other Names:
  • Sterile water

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
recurrence rate after surgical treatment of tumour
Time Frame: 5 years after treatment
recurrence rate after surgical treatment of tumour
5 years after treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zealand University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2020

Primary Completion (Estimated)

May 1, 2025

Study Completion (Estimated)

May 1, 2027

Study Registration Dates

First Submitted

May 23, 2019

First Submitted That Met QC Criteria

May 23, 2019

First Posted (Actual)

May 24, 2019

Study Record Updates

Last Update Posted (Actual)

January 30, 2024

Last Update Submitted That Met QC Criteria

January 28, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ZUHURO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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