Ignite Creation Date:
2025-12-25 @ 4:17 AM
Ignite Modification Date:
2025-12-26 @ 3:17 AM
Study NCT ID:
NCT03962920
Status:
RECRUITING
Last Update Posted:
2024-01-30
First Post:
2019-05-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Personalized Treatment of Urogenital Cancers Depends on the Microbiome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000078304', 'term': 'Tigecycline'}], 'ancestors': [{'id': 'D013754', 'term': 'Tetracyclines'}, {'id': 'D009279', 'term': 'Naphthacenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 28}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2027-05-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-01-28', 'studyFirstSubmitDate': '2019-05-23', 'studyFirstSubmitQcDate': '2019-05-23', 'lastUpdatePostDateStruct': {'date': '2024-01-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-05-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-05-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'recurrence rate after surgical treatment of tumour', 'timeFrame': '5 years after treatment', 'description': 'recurrence rate after surgical treatment of tumour'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Microbial Disease']}, 'descriptionModule': {'briefSummary': 'This is a randomized controlled trial where patients undergoing surgical treatment for urogenital cancers will be randomized in a two arms study: surgical treatment + antibiotics OR surgical treatment + placebo.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Biopsy verified diagnosis of urological cancer, localized disease\n\nExclusion Criteria:\n\n* Hospitalization within three months of surgery\n* Antibiotics within three months of surgery\n* Infectious disease, including UTI's within three months of surgery\n* History of cancers of the genitourinary tract\n* Diabetes"}, 'identificationModule': {'nctId': 'NCT03962920', 'briefTitle': 'Personalized Treatment of Urogenital Cancers Depends on the Microbiome', 'organization': {'class': 'OTHER', 'fullName': 'Zealand University Hospital'}, 'officialTitle': 'Personalized Treatment of Urogenital Cancers Depends on the Microbiome', 'orgStudyIdInfo': {'id': 'ZUHURO'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Surgical treatment + antibiotics', 'description': 'Use antibiotic', 'interventionNames': ['Drug: Tigecycline 50 MG']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'surgical treatment + placebo', 'description': 'Use placebo', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'Tigecycline 50 MG', 'type': 'DRUG', 'otherNames': ['Tigecycline'], 'description': 'Local instillation of drug directly to the tumour tissue', 'armGroupLabels': ['Surgical treatment + antibiotics']}, {'name': 'Placebo', 'type': 'OTHER', 'otherNames': ['Sterile water'], 'description': 'Local instillation of sterile water directly to the tumour tissue', 'armGroupLabels': ['surgical treatment + placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '4000', 'city': 'Roskilde', 'status': 'RECRUITING', 'country': 'Denmark', 'contacts': [{'name': 'Nessn H. Azawi, M.D.', 'role': 'CONTACT', 'email': 'nesa@regionsjaelland.dk', 'phone': '004526393034'}, {'name': 'Nessn Azawi, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Zealand University Hospital', 'geoPoint': {'lat': 55.64152, 'lon': 12.08035}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zealand University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}