CystoscopyNCT04019756
IDENTIFICATION OF URINARY MICROBIOTE IN PATIENTS WITH DIAGNOSTIC-RELATED CYSTOSCOPY
An observational study of Cystoscopy, run by Assistance Publique Hopitaux De Marseille.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cystoscopy
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2019to 30 Sep 2021
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
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.
Read the 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.
- Conditions
- Cystoscopy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2019
- Study start1 Sep 2019 (estimated)
- Primary completion30 Mar 2020 (estimated)
- Study completion30 Sep 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CystoscopyStudies of the same condition, open and under way.
- More trials run by Assistance Publique Hopitaux De MarseilleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 100 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04019756
- Sponsor's protocol ID
- 2018-60
- Other IDs
- 2018-60
- Status last verified
- Jul 2019
- First submitted
- 9 Jul 2019
- Last updated
- 15 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- IDENTIFICATION OF URINARY MICROBIOTE IN PATIENTS WITH DIAGNOSTIC-RELATED CYSTOSCOPY
- ClinicalTrials.gov ID
- NCT04019756
- Acronym / sponsor ID
- 2018-60
- Conditions
- Cystoscopy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- 1 Sep 2019 (estimated)
- Primary completion
- 30 Mar 2020 (estimated)
- Study completion
- 30 Sep 2021 (estimated)
- First posted
- 15 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Other
- Target follow-up
- 6 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of Cystoscopy, run by Assistance Publique Hopitaux De Marseille.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Didier Raoult (04 13 73 24 01, didier.raoult@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Matrix Assisted Laser Desorption Ionisation - Time of Flight (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2019.