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RecruitingNCT03962920Updated Jan 30, 2024

Personalized Treatment of Urogenital Cancers Depends on the Microbiome

An interventional study of Tigecycline 50 MG and Placebo in Microbial Disease, sponsored by Zealand University Hospital. Recruiting at 1 site in Denmark. Open to participants aged 40 Years to 70 Years. Per ClinicalTrials.gov, last updated 2024-01-30.

Sponsored by Zealand University Hospital · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by May 2025, 1 year 5 months ago, but the record still lists the study as recruiting.
  • Started May 2020; still recruiting 6 years 5 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
28
Allocation
Randomized
Ages
40 Years to 70 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Microbial Disease

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03

In context

Urogenital Neoplasms

135 studies on the registry are indexed under Urogenital Neoplasms; 47 are open to participants now.

This study's planned enrollment of 28 is below the median of 60 across 93 interventional studies indexed under Urogenital Neoplasms.

Browse Urogenital Neoplasms studies →

Lead sponsor

Zealand University Hospital is the lead sponsor of 234 studies on the registry; 51 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Biopsy verified diagnosis of urological cancer, localized disease

Exclusion criteria

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
28 participants (estimated)

Study arms

  • Active comparator
    Surgical treatment + antibiotics

    Use antibiotic

    Drug: Tigecycline 50 MG

  • Placebo comparator
    surgical treatment + placebo

    Use placebo

    Other: Placebo

Interventions

  • DrugTigecycline 50 MG

    Local instillation of drug directly to the tumour tissue

    Also known as: Tigecycline

  • OtherPlacebo

    Local instillation of sterile water directly to the tumour tissue

    Also known as: Sterile water

06

What researchers measure

Primary outcomes

  1. recurrence rate after surgical treatment of tumour

    recurrence rate after surgical treatment of tumour

    Time frame: 5 years after treatment

07

Study locations

1 of 1 sites recruiting
  • Zealand University Hospital
    Roskilde, 4000, Denmark
    • Nessn H. Azawi, M.D. · Contact · nesa@regionsjaelland.dk · 004526393034
    • Nessn Azawi, M.D. · Principal investigator
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 30, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03962920
Lead sponsor
Zealand University Hospital
Responsible party
Sponsor
First posted
May 24, 2019
Start date
May 1, 2020
Primary completion
May 1, 2025 (estimated)
Completion
May 1, 2027 (estimated)
Last update
Jan 30, 2024

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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No contact was published for this record. The registry link below has the sponsor’s details.

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