IDENTIFICATION OF URINARY MICROBIOTE IN PATIENTS WITH DIAGNOSTIC-RELATED CYSTOSCOPY
1 other identifier
observational
100
0 countries
N/A
Brief Summary
Identify by culture the urinary microbiota of patients with bladder cancer (at the time of diagnosis) and controls.Identify by metagenomics the urinary microbiota of patients with bladder cancer (at the time of diagnosis) and controls.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Sep 2019
Typical duration for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 9, 2019
CompletedFirst Posted
Study publicly available on registry
July 15, 2019
CompletedStudy Start
First participant enrolled
September 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 30, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
September 30, 2021
CompletedJuly 15, 2019
July 1, 2019
7 months
July 9, 2019
July 12, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Matrix Assisted Laser Desorption Ionisation - Time of Flight
A matrix and a sample are deposited on a target. Pulsed laser shots desorb the matrix which then ionizes the sample by charge transfer. By potential differences applied to lenses, the ionized molecules are accelerated and then transferred to the TOF analyzer. This analyzer will allow the separation of the ionized molecules which will depend on their mass-to-charge ratio.
1 day
Study Arms (1)
Patients with cancer
50 patients ultimately diagnosed with bladder cancer and 50 control patients (diagnosis of cancer reversed at cystoscopy or cystoscopy for another cause)
Eligibility Criteria
Any present patient meeting the inclusion criteria of the study will be offered to participate in the study. For this purpose during the hospitalization or consultation of the patient, the investigator or his collaborator.
You may qualify if:
- Person receiving a cystoscopy in the context of a suspicion of bladder cancer
- Person and / or legal guardian for minors who have been informed about the study and have not expressed opposition to participate in the study.
- Affiliated person or beneficiary of a social security scheme.
You may not qualify if:
- Vulnerable person: pregnant, parturient or nursing woman,
- person under guardianship or curatorship, or deprived of liberty by a judicial or administrative decision.
- Person treated with antibiotics
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- OTHER
- Target Duration
- 6 Months
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 9, 2019
First Posted
July 15, 2019
Study Start
September 1, 2019
Primary Completion
March 30, 2020
Study Completion
September 30, 2021
Last Updated
July 15, 2019
Record last verified: 2019-07