Ignite Creation Date:
2025-12-24 @ 11:18 PM
Ignite Modification Date:
2025-12-25 @ 8:58 PM
Study NCT ID:
NCT06675656
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-11-05
First Post:
2024-11-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Predictive Role of Microbiome in Patients With Urothelial Carcinoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001749', 'term': 'Urinary Bladder Neoplasms'}], 'ancestors': [{'id': 'D014571', 'term': 'Urologic Neoplasms'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D001745', 'term': 'Urinary Bladder Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003672', 'term': 'Defecation'}], 'ancestors': [{'id': 'D004068', 'term': 'Digestive System Physiological Phenomena'}, {'id': 'D055688', 'term': 'Digestive System and Oral Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 420}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-11', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2035-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-11-04', 'studyFirstSubmitDate': '2024-11-04', 'studyFirstSubmitQcDate': '2024-11-04', 'lastUpdatePostDateStruct': {'date': '2024-11-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-11-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Establish the change of microbial profile in high-grade NMIBC patients after BCG administration', 'timeFrame': '2 years', 'description': 'Establish the change of urinary and fecal microbiome richness and diversity, and immunophenotype in bladder carcinoma patients after intravesical BCG treatment.'}], 'secondaryOutcomes': [{'measure': 'The predictive role of microbiome in BCG responsiveness', 'timeFrame': '11 years', 'description': 'Categorize potential candidates for BCG therapy, based on the microbiota pre-therapy.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Urinary Bladder Cancer']}, 'descriptionModule': {'briefSummary': 'This study aims to establish the microbiota composition as a predictive tool for the response to the intravesical immunotherapy with Bacillus Calmette-Guérin (BCG) and 2 different chemotherapies schemes.\n\nIn this prospective cohort study patients with low/intermediate/high risk non muscle invasive bladder carcinoma (NMIBC) that undergo BCG/chemo treatment will be enrolled to collect urine stool and blood at different endpoints. Microbiota, short-chain fatty acids and immunophenotype will be quantified to develop a predictive screening platform, which might also integrate traditional urinary cytology and FISH data.', 'detailedDescription': 'The purpose of this research is to understand the possible use of microbial profile from catheterized urine and feces of patients with NMIBC to categorize patients in two groups: those likely to respond positively and those unlikely to respond to the therapy. Goal of this study is to identify the predictive role of the microbiome to therapy response, thus allowing clinicians to deliver the most appropriate treatment based on the microbiome (microbiome-personalized therapy).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adults with diagnosis of NMIBC, both first diagnosis or relapsing NMIBC.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults aged ≥ 18 years, all able to signed informed consent form;\n* Diagnosis of NMIBC provided by an experience pathology, by using tissue specimens that were staged according to the TNM classification and morphoarchitectural criteria according to the WHO classification.\n\nExclusion Criteria:\n\n* Participants with ongoing urinary tract infection;\n* Antibiotic treatment within the last month;\n* Immuno-/chemo- therapy within the past 3 months;\n* Chronic immunosuppressive therapy;\n* Additional major diagnosis known to affect the gut or bladder microbiota;\n* Use of probiotics;\n* Uncontrolled diabetes;\n* Participants with other malignancy or previous history of oncological or autoimmune diseases.'}, 'identificationModule': {'nctId': 'NCT06675656', 'briefTitle': 'Predictive Role of Microbiome in Patients With Urothelial Carcinoma', 'organization': {'class': 'OTHER', 'fullName': 'IRCCS San Raffaele'}, 'officialTitle': 'Predictive Role of Microbiome in Patients With Urothelial Carcinoma', 'orgStudyIdInfo': {'id': 'UROBIOTA'}}, 'armsInterventionsModule': {'armGroups': [{'label': '1M. Predictive role of microbiome in male with low grade NMIBC undergoing Gem/Dox.', 'description': 'Predictive role of microbiome in male with low grade non-muscle invasive bladder carcinoma undergoing Gem/Dox.', 'interventionNames': ['Other: DNA extraction from urine, stool and biopsy. Isolation of serum and PBMC from peripheral blood.']}, {'label': '1F. Predictive role of microbiome in female with low grade NMIBC undergoing Gem/Dox.', 'description': 'Predictive role of microbiome in female with low grade non-muscle invasive bladder carcinoma undergoing Gem/Dox.', 'interventionNames': ['Other: DNA extraction from urine, stool and biopsy. Isolation of serum and PBMC from peripheral blood.']}, {'label': '2M. Predictive role of microbiome in male with intermediate grade NMIBC undergoing MMC.', 'description': 'Predictive role of microbiome in male with intermediate grade non-muscle invasive bladder carcinoma undergoing MMC.', 'interventionNames': ['Other: DNA extraction from urine, stool and biopsy. Isolation of serum and PBMC from peripheral blood.']}, {'label': '2F. Predictive role of microbiome in female with intermediate grade NMIBC undergoing MMC.', 'description': 'Predictive role of microbiome in female with intermediate grade non-muscle invasive bladder carcinoma undergoing MMC.', 'interventionNames': ['Other: DNA extraction from urine, stool and biopsy. Isolation of serum and PBMC from peripheral blood.']}, {'label': '3M. Predictive role of microbiome in male with high grade NMIBC undergoing BCG.', 'description': 'Predictive role of microbiome in male with high grade non-muscle invasive bladder carcinoma undergoing BCG.', 'interventionNames': ['Other: DNA extraction from urine, stool and biopsy. Isolation of serum and PBMC from peripheral blood.']}, {'label': '3F. Predictive role of microbiome in female with high grade NMIBC undergoing BCG.', 'description': 'Predictive role of microbiome in female with high grade non-muscle invasive bladder carcinoma undergoing BCG.', 'interventionNames': ['Other: DNA extraction from urine, stool and biopsy. Isolation of serum and PBMC from peripheral blood.']}], 'interventions': [{'name': 'DNA extraction from urine, stool and biopsy. Isolation of serum and PBMC from peripheral blood.', 'type': 'OTHER', 'description': 'DNA extraction from urine, stool and biopsy for microbiome analysis. Isolation of peripheral blood mononuclear cells from peripheral blood for immunophenotypic analysis, and isolation of serum for analysis of cytokines and bacterial metabolites.', 'armGroupLabels': ['1F. Predictive role of microbiome in female with low grade NMIBC undergoing Gem/Dox.', '1M. Predictive role of microbiome in male with low grade NMIBC undergoing Gem/Dox.', '2F. Predictive role of microbiome in female with intermediate grade NMIBC undergoing MMC.', '2M. Predictive role of microbiome in male with intermediate grade NMIBC undergoing MMC.', '3F. Predictive role of microbiome in female with high grade NMIBC undergoing BCG.', '3M. Predictive role of microbiome in male with high grade NMIBC undergoing BCG.']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Massimo Alfano, PhD', 'role': 'CONTACT', 'email': 'alfano.massimo@hsr.it', 'phone': '+39-022643', 'phoneExt': '6351'}, {'name': 'Marco Moschini, MD, PhD', 'role': 'CONTACT', 'email': 'moschini.marco@hsr.it', 'phone': '+39-022643', 'phoneExt': '9742'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'IRCCS San Raffaele', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PhD', 'investigatorFullName': 'Massimo Alfano', 'investigatorAffiliation': 'IRCCS San Raffaele'}}}}