IDENTIFICATION OF URINARY MICROBIOTE IN PATIENTS WITH DIAGNOSTIC-RELATED CYSTOSCOPY

Cystoscopy Clinical Trial

Official title:

IDENTIFICATION OF URINARY MICROBIOTE IN PATIENTS WITH DIAGNOSTIC-RELATED CYSTOSCOPY

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04019756
• Other study ID #: 2018-60
• Secondary ID: 2018-60
• Status: Not yet recruiting
• Start date: September 1, 2019
• Est. completion date: September 30, 2021

Study information

• Verified date: July 2019
• Source: Assistance Publique Hopitaux De Marseille
• Contact: Didier Raoult
• Phone: 04 13 73 24 01
• Email: didier.raoult[@]gmail.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: September 30, 2021
• Est. primary completion date: March 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cystoscopy

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique Hopitaux De Marseille

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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