Ignite Creation Date:
2025-12-24 @ 11:19 PM
Ignite Modification Date:
2025-12-25 @ 9:01 PM
Study NCT ID:
NCT04019756
Status:
UNKNOWN
Last Update Posted:
2019-07-15
First Post:
2019-07-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
IDENTIFICATION OF URINARY MICROBIOTE IN PATIENTS WITH DIAGNOSTIC-RELATED CYSTOSCOPY
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'targetDuration': '6 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2019-09-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-07', 'completionDateStruct': {'date': '2021-09-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-07-12', 'studyFirstSubmitDate': '2019-07-09', 'studyFirstSubmitQcDate': '2019-07-12', 'lastUpdatePostDateStruct': {'date': '2019-07-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-07-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-03-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Matrix Assisted Laser Desorption Ionisation - Time of Flight', 'timeFrame': '1 day', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cystoscopy']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nBladder 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.\n\nUrine 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.\n\nBCG 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.\n\nThus microbiota composed mainly of Actinobacteria could be associated with a lower incidence of bladder cancers in women.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Person receiving a cystoscopy in the context of a suspicion of bladder cancer\n* Person and / or legal guardian for minors who have been informed about the study and have not expressed opposition to participate in the study.\n* Affiliated person or beneficiary of a social security scheme.\n\nExclusion Criteria:\n\n* Vulnerable person: pregnant, parturient or nursing woman,\n* person under guardianship or curatorship, or deprived of liberty by a judicial or administrative decision.\n* Person treated with antibiotics'}, 'identificationModule': {'nctId': 'NCT04019756', 'briefTitle': 'IDENTIFICATION OF URINARY MICROBIOTE IN PATIENTS WITH DIAGNOSTIC-RELATED CYSTOSCOPY', 'organization': {'class': 'OTHER', 'fullName': 'Assistance Publique Hopitaux De Marseille'}, 'officialTitle': 'IDENTIFICATION OF URINARY MICROBIOTE IN PATIENTS WITH DIAGNOSTIC-RELATED CYSTOSCOPY', 'orgStudyIdInfo': {'id': '2018-60'}, 'secondaryIdInfos': [{'id': '2018-60', 'type': 'REGISTRY', 'domain': 'APHM'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients with cancer', 'description': '50 patients ultimately diagnosed with bladder cancer and 50 control patients (diagnosis of cancer reversed at cystoscopy or cystoscopy for another cause)'}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Didier Raoult', 'role': 'CONTACT', 'email': 'didier.raoult@gmail.com', 'phone': '04 13 73 24 01'}, {'name': 'Alexandra Giuliani', 'role': 'CONTACT', 'email': 'promotion.interne@aphm.fr', 'phone': '04 91 38 28 70'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assistance Publique Hopitaux De Marseille', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}