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IDENTIFICATION OF URINARY MICROBIOTE IN PATIENTS WITH DIAGNOSTIC-RELATED CYSTOSCOPY
| Condition or disease |
|---|
| Cystoscopy |
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.
| Study Type : | Observational [Patient Registry] |
| Estimated Enrollment : | 100 participants |
| Observational Model: | Other |
| Time Perspective: | Other |
| Target Follow-Up Duration: | 6 Months |
| Official Title: | IDENTIFICATION OF URINARY MICROBIOTE IN PATIENTS WITH DIAGNOSTIC-RELATED CYSTOSCOPY |
| Estimated Study Start Date : | September 1, 2019 |
| Estimated Primary Completion Date : | March 30, 2020 |
| Estimated Study Completion Date : | September 30, 2021 |
| Group/Cohort |
|---|
|
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)
|
- 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.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
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
| Contact: Didier Raoult | 04 13 73 24 01 | didier.raoult@gmail.com | |
| Contact: Alexandra Giuliani | 04 91 38 28 70 | promotion.interne@aphm.fr |
| Tracking Information | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| First Submitted Date | July 9, 2019 | ||||||||
| First Posted Date | July 15, 2019 | ||||||||
| Last Update Posted Date | July 15, 2019 | ||||||||
| Estimated Study Start Date | September 1, 2019 | ||||||||
| Estimated Primary Completion Date | March 30, 2020 (Final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures |
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.
|
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| Original Primary Outcome Measures | Same as current | ||||||||
| Change History | No Changes Posted | ||||||||
| Current Secondary Outcome Measures | Not Provided | ||||||||
| Original Secondary Outcome Measures | Not Provided | ||||||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title | IDENTIFICATION OF URINARY MICROBIOTE IN PATIENTS WITH DIAGNOSTIC-RELATED CYSTOSCOPY | ||||||||
| Official Title | IDENTIFICATION OF URINARY MICROBIOTE IN PATIENTS WITH DIAGNOSTIC-RELATED CYSTOSCOPY | ||||||||
| 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. | ||||||||
| 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. |
||||||||
| Study Type | Observational [Patient Registry] | ||||||||
| Study Design | Observational Model: Other Time Perspective: Other |
||||||||
| Target Follow-Up Duration | 6 Months | ||||||||
| Biospecimen | Not Provided | ||||||||
| 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. | ||||||||
| Condition | Cystoscopy | ||||||||
| Intervention | Not Provided | ||||||||
| Study Groups/Cohorts | 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)
|
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| Publications * | Not Provided | ||||||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status | Not yet recruiting | ||||||||
| Estimated Enrollment |
100 | ||||||||
| Original Estimated Enrollment | Same as current | ||||||||
| Estimated Study Completion Date | September 30, 2021 | ||||||||
| Estimated Primary Completion Date | March 30, 2020 (Final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria |
Inclusion Criteria:
Exclusion Criteria:
|
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| Sex/Gender |
|
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| Ages | 18 Years and older (Adult, Older Adult) | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts |
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| Listed Location Countries | Not Provided | ||||||||
| Removed Location Countries | |||||||||
| Administrative Information | |||||||||
| NCT Number | NCT04019756 | ||||||||
| Other Study ID Numbers | 2018-60 2018-60 ( Registry Identifier: APHM ) |
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| Has Data Monitoring Committee | No | ||||||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement | Not Provided | ||||||||
| Responsible Party | Assistance Publique Hopitaux De Marseille | ||||||||
| Study Sponsor | Assistance Publique Hopitaux De Marseille | ||||||||
| Collaborators | Not Provided | ||||||||
| Investigators | Not Provided | ||||||||
| PRS Account | Assistance Publique Hopitaux De Marseille | ||||||||
| Verification Date | July 2019 | ||||||||
