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Personalized Treatment of Urogenital Cancers Depends on the Microbiome

Sponsor
Zealand University Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT03962920
Collaborator
(none)
28
Enrollment
1
Location
2
Arms
84
Anticipated Duration (Months)
0.3
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Tigecycline 50 MG
  • Other: Placebo
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
28 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
Personalized Treatment of Urogenital Cancers Depends on the Microbiome
Actual Study Start Date :
May 1, 2020
Anticipated Primary Completion Date :
May 1, 2025
Anticipated Study Completion Date :
May 1, 2027

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. recurrence rate after surgical treatment of tumour [5 years after treatment]

      recurrence rate after surgical treatment of tumour

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    40 Years to 70 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Zealand University Hospital Roskilde Denmark 4000

    Sponsors and Collaborators

    • Zealand University Hospital

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Zealand University Hospital
    ClinicalTrials.gov Identifier:
    NCT03962920
    Other Study ID Numbers:
    • ZUHURO
    First Posted:
    May 24, 2019
    Last Update Posted:
    Sep 24, 2021
    Last Verified:
    Sep 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Urogenital Neoplasms
    Tigecycline

    Study Results

    No Results Posted as of Sep 24, 2021