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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04019756
Recruitment Status : Not yet recruiting
First Posted : July 15, 2019
Last Update Posted : July 15, 2019
Information provided by (Responsible Party):
Assistance Publique Hopitaux De Marseille

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.

Condition or disease

Detailed Description:

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.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 100 participants
Observational Model: Other
Time Perspective: Other
Target Follow-Up Duration: 6 Months
Estimated Study Start Date : September 1, 2019
Estimated Primary Completion Date : March 30, 2020
Estimated Study Completion Date : September 30, 2021

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)

Primary Outcome Measures :
  1. Matrix Assisted Laser Desorption Ionisation - Time of Flight [ Time Frame: 1 day ]
    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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
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.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04019756

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Contact: Didier Raoult 04 13 73 24 01
Contact: Alexandra Giuliani 04 91 38 28 70

Sponsors and Collaborators
Assistance Publique Hopitaux De Marseille

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Responsible Party: Assistance Publique Hopitaux De Marseille Identifier: NCT04019756     History of Changes
Other Study ID Numbers: 2018-60
2018-60 ( Registry Identifier: APHM )
First Posted: July 15, 2019    Key Record Dates
Last Update Posted: July 15, 2019
Last Verified: July 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No