Ignite Creation Date:
2025-12-25 @ 3:05 AM
Ignite Modification Date:
2026-01-01 @ 1:33 AM
Study NCT ID:
NCT07080333
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-07-23
First Post:
2025-07-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
MICROBIOTA AND BLADDER CANCER
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001706', 'term': 'Biopsy'}], 'ancestors': [{'id': 'D003581', 'term': 'Cytodiagnosis'}, {'id': 'D003584', 'term': 'Cytological Techniques'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D003949', 'term': 'Diagnostic Techniques, Surgical'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 95}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-10-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2028-10-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-15', 'studyFirstSubmitDate': '2025-07-15', 'studyFirstSubmitQcDate': '2025-07-15', 'lastUpdatePostDateStruct': {'date': '2025-07-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-07-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-04-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The biodiversity of the bacterial bladder microbiota by global metagenomics', 'timeFrame': '36 months', 'description': 'description of biodiversity of bacterial bladder microbiota'}], 'secondaryOutcomes': [{'measure': 'Global biodiversity of viral microbiota by metagenomics', 'timeFrame': '36 months', 'description': 'description of global biodiversity of viral microbiota'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['bladder; cancer; microbiota'], 'conditions': ['Bladder (Urothelial, Transitional Cell) Cancer']}, 'descriptionModule': {'briefSummary': 'In France, bladder cancer (BC) is the fourth leading cause of cancer (14,000 new cases per year). It affects older men (\\>60 years old) and smoking is the main identified risk factor (RF). The persistence of a high sex ratio despite the increase in smoking among women has led to research into other environmental RFs for BC, which may include the microbiota.\n\nRecently, the concept of urinary microbiota in asymptomatic patients has been accepted. Studies on the urinary microbiota have shown dysbiosis associated with certain urogenital pathologies. Thus, similar to certain dysbiosis of the colonic mucosa microbiota associated with CRC, it is possible that certain bacteria or viruses in the bladder tissue microbiota may be involved in bladder carcinogenesis. An epidemiological study conducted by our laboratory showed a prevalence of BC of 14% (7/50) in patients carrying the bacterium Actinotignum schaalii in their urine. While studies have analysed the urinary microbiota of patients with BC, those comparing the microbiota of cancerous bladder tissue with that of healthy tissue in patients with BC remain few in number, involve a limited number of patients, use uncontrolled sample collection, and have all used 16S rDNA-targeted metagenomics methods to study the composition of the microbiota. The authors show a difference in biodiversity between the microbiota of cancerous bladder tissue and that of healthy tissue.\n\nThe team hopes to confirm these preliminary results with a multicentre study using a more comprehensive genomic method, global metagenomics. The microbiota of cancerous bladder tissue will be compared with that of healthy bladder tissue in the same patient to highlight any bacterial or viral dysbiosis associated with the cancerous area.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age \\> 18 years old\n* Male\n* First RTUV for suspected CV in the presence of macroscopic haematuria or other clinical signs and/or urinary cytology and/or cystoscopy and/or imaging tests suggestive of CV\n* Signed informed consent form\n* Affiliation with a social security scheme\n\nExclusion Criteria:\n\n* Antibiotic use within 3 months prior to inclusion\n* Current urinary tract infection (urine culture recommended by the AFU prior to RTUV)\n* History of surgical treatment of the urinary and genital tracts within the last 6 months prior to inclusion\n* History of RTUV\n* History of pelvic radiotherapy\n* Interstitial cystitis\n* Patients with an indwelling urinary catheter\n* Vulnerable patients: minors, patients under guardianship or curatorship\n* Patients with benign tumours after receipt of the pathological report (inverted papilloma, non-tumour inflammatory lesion)'}, 'identificationModule': {'nctId': 'NCT07080333', 'acronym': 'MICROBLADDERK', 'briefTitle': 'MICROBIOTA AND BLADDER CANCER', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire de Nice'}, 'officialTitle': 'BLADDER MICROBIOTA AND BLADDER CANCER', 'orgStudyIdInfo': {'id': '23-API-02'}, 'secondaryIdInfos': [{'id': '2025-A01185-44', 'type': 'OTHER', 'domain': 'IDRCB'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'patient with suspected bladder cancer', 'interventionNames': ['Biological: biopsy']}], 'interventions': [{'name': 'biopsy', 'type': 'BIOLOGICAL', 'description': "After verifying the patient's identity, obtaining their informed consent and confirming that there are no immediate contraindications to performing biopsies (haemorrhagic and infectious), the patient will be prepared for RTUV, which will be performed by cystoscopy under anaesthesia in the operating theatre.", 'armGroupLabels': ['patient with suspected bladder cancer']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06141', 'city': 'Cannes', 'country': 'France', 'contacts': [{'name': 'Romain HAIDER', 'role': 'CONTACT', 'email': 'R.HAIDER@ch-cannes.fr', 'phone': '04 92 18 37 70'}, {'name': 'Romain HAIDER', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Cannes Hospital', 'geoPoint': {'lat': 43.55135, 'lon': 7.01275}}, {'zip': '13000', 'city': 'Marseille', 'country': 'France', 'contacts': [{'name': 'Romain BOISSIER', 'role': 'CONTACT', 'email': 'Romain.Boissier@ap-hm.fr', 'phone': '04 91 43 51 70'}, {'name': 'Romain BOISSIER', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Marseille university Hospital', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}, {'zip': '06507', 'city': 'Menton', 'country': 'France', 'contacts': [{'name': 'Khaled YOUSSEF', 'role': 'CONTACT', 'email': 'k.youssef@ch-menton.fr', 'phone': '04.93.28.72.60'}, {'name': 'Khaled YOUSSEF', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Menton Hospital', 'geoPoint': {'lat': 43.77649, 'lon': 7.50435}}, {'zip': '06000', 'city': 'Nice', 'country': 'France', 'contacts': [{'name': 'Alice GAUDART', 'role': 'CONTACT', 'email': 'gaudart.a@chu-nice.fr', 'phone': '0492036214'}, {'name': 'Romain LOTTE', 'role': 'CONTACT', 'email': 'lotte.r@chu-nice.fr'}, {'name': 'Mathieu DURANT', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Nice University Hospital', 'geoPoint': {'lat': 43.70313, 'lon': 7.26608}}, {'zip': '30029', 'city': 'Nîmes', 'country': 'France', 'contacts': [{'name': 'Stephane DROUPY', 'role': 'CONTACT', 'email': 'droupy.s@chu-nimes.fr', 'phone': '04 92 03 46 72'}, {'name': 'Stephane DROUPY', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Nimes University hospital', 'geoPoint': {'lat': 43.83665, 'lon': 4.35788}}, {'zip': '75018', 'city': 'Paris', 'country': 'France', 'contacts': [{'name': 'Jean françois HERMIEU', 'role': 'CONTACT', 'email': 'jean-francois.hermieu@bch.aphp.fr', 'phone': '01 40 25 71 03'}, {'name': 'Jean François HERMIEU', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Paris University Hospital', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '35033', 'city': 'Rennes', 'country': 'France', 'contacts': [{'name': 'Romain MATHIEU', 'role': 'CONTACT', 'email': 'romain.MATHIEU@chu-rennes.fr', 'phone': '02 99 28 42 70'}, {'name': 'Romain MATHIEU', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Rennes University Hospital', 'geoPoint': {'lat': 48.11109, 'lon': -1.67431}}, {'zip': '37044', 'city': 'Tours', 'country': 'France', 'contacts': [{'name': 'Ali BOURGI', 'role': 'CONTACT', 'email': 'ali.bourgi@univ-tours.fr', 'phone': '02 47 47 39 17'}], 'facility': 'Tours University Hospital', 'geoPoint': {'lat': 47.39484, 'lon': 0.70398}}], 'centralContacts': [{'name': 'Alice GAUDART', 'role': 'CONTACT', 'email': 'gaudart.a@chu-nice.fr', 'phone': '04 92 03 62 14'}, {'name': 'Romain LOTTE, MCUPH', 'role': 'CONTACT', 'email': 'lotte.r@chu-nice.fr', 'phone': '04 92 03 62 14'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire de Nice', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}