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Personalized Treatment of Urogenital Cancers Depends on the Microbiome

Primary Purpose

Microbial Disease

Status
Recruiting
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Tigecycline 50 MG
Placebo
Sponsored by
Zealand University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Microbial Disease

Eligibility Criteria

40 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Zealand University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Surgical treatment + antibiotics

surgical treatment + placebo

Arm Description

Use antibiotic

Use placebo

Outcomes

Primary Outcome Measures

recurrence rate after surgical treatment of tumour
recurrence rate after surgical treatment of tumour

Secondary Outcome Measures

Full Information

First Posted
May 23, 2019
Last Updated
September 20, 2021
Sponsor
Zealand University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03962920
Brief Title
Personalized Treatment of Urogenital Cancers Depends on the Microbiome
Official Title
Personalized Treatment of Urogenital Cancers Depends on the Microbiome
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Recruiting
Study Start Date
May 1, 2020 (Actual)
Primary Completion Date
May 1, 2025 (Anticipated)
Study Completion Date
May 1, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Zealand University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Microbial Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
28 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Surgical treatment + antibiotics
Arm Type
Active Comparator
Arm Description
Use antibiotic
Arm Title
surgical treatment + placebo
Arm Type
Placebo Comparator
Arm Description
Use placebo
Intervention Type
Drug
Intervention Name(s)
Tigecycline 50 MG
Other Intervention Name(s)
Tigecycline
Intervention Description
Local instillation of drug directly to the tumour tissue
Intervention Type
Other
Intervention Name(s)
Placebo
Other Intervention Name(s)
Sterile water
Intervention Description
Local instillation of sterile water directly to the tumour tissue
Primary Outcome Measure Information:
Title
recurrence rate after surgical treatment of tumour
Description
recurrence rate after surgical treatment of tumour
Time Frame
5 years after treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Zealand University Hospital
City
Roskilde
ZIP/Postal Code
4000
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nessn H. Azawi, M.D.
Phone
004526393034
Email
nesa@regionsjaelland.dk
First Name & Middle Initial & Last Name & Degree
Nessn Azawi, M.D.

12. IPD Sharing Statement

Learn more about this trial

Personalized Treatment of Urogenital Cancers Depends on the Microbiome

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