Personalized Treatment of Urogenital Cancers Depends on t... | NCT03962920

Studies
Personalized Treatment of Urogenital Cancers Depends on the Microbiome

NCT03962920

Sponsor

Zealand University Hospital

Status

Recruiting

Last Update Posted

Jan 30, 2024Actual

Enrollment

28Estimated

Phase

Not Applicable

Conditions

Microbial Disease

Interventions

Tigecycline 50 MG
Placebo

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2024

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 1, 2020Actual

Primary Completion Date

May 1, 2025Estimated

Completion Date

May 1, 2027Estimated

First Submitted Date

May 23, 2019

First Submission Date that Met QC Criteria

May 23, 2019

First Posted Date

May 24, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 28, 2024

Last Update Posted Date

Jan 30, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

28Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Surgical treatment + antibiotics	Active Comparator	Use antibiotic	Drug: Tigecycline 50 MG
surgical treatment + placebo	Placebo Comparator	Use placebo	Other: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Tigecycline 50 MG	Drug	Local instillation of drug directly to the tumour tissue	Surgical treatment + antibiotics

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

40 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Zealand University Hospital	Recruiting	Roskilde		4000	Denmark

Intervention Browse Module

MeSH Terms

ID	Term
D000078304	Tigecycline

Ancestor Terms

ID	Term
D013754	Tetracyclines
D009279	Naphthacenes
D011084	Polycyclic Aromatic Hydrocarbons
D006841	Hydrocarbons, Aromatic

Browse Leaves

Not provided

Browse Branches

Not provided