IDENTIFICATION OF URINARY MICROBIOTE IN PATIENTS WITH DIAGNOSTIC-RELATED CYSTOSCOPY

NCT ID: NCT04019756

Last Updated: 2019-07-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-09-01

Study Completion Date

2021-09-30

Brief Summary

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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.

Detailed Description

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Relationships between the human microbiota and various pathologies such as cancer have been demonstrated. The microbiota would have an influence on the effectiveness of anticancer treatments.

Bladder cancers are five times more common in men than women, and this difference in incidence has long been explained by a higher smoking rate among men. However, the increase in smoking among women has not led, as in the case of lung cancer, to a significant increase in bladder cancer among them.

Urine bladder has long been considered "sterile" by generations of researchers. Recent studies have shown that most urine is not sterile but instead contains a different microbiota in both men and women. In women Actinobacteria, including Mycobacteria, and Bacteroidetes have been detected.

BCG therapy is used in the treatment of bladder cancer. BCG, in addition to being a vaccine to prevent tuberculosis, is a mycobacterium belonging to the phylum Actinobacteria \[4\]. Controversial studies have suggested the same potential for Lactobacillus casei. Lactobacillii are Firmicutes found both in the urinary microbiota of men and women.

Thus microbiota composed mainly of Actinobacteria could be associated with a lower incidence of bladder cancers in women.

Conditions

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Cystoscopy

Study Design

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Observational Model Type

OTHER

Study Time Perspective

OTHER

Study Groups

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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)

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assistance Publique Hopitaux De Marseille

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Central Contacts

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Didier Raoult

Role: CONTACT

04 13 73 24 01

Alexandra Giuliani

Role: CONTACT

04 91 38 28 70

Other Identifiers

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2018-60

Identifier Type: REGISTRY

Identifier Source: secondary_id

2018-60

Identifier Type: -

Identifier Source: org_study_id

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