Ignite Creation Date:
2025-12-24 @ 5:44 PM
Ignite Modification Date:
2025-12-25 @ 3:12 PM
Study NCT ID:
NCT07253168
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-11-28
First Post:
2025-11-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Tumor Integrating Gut Microbiota in bREast Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 240}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-12-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2028-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-19', 'studyFirstSubmitDate': '2025-11-19', 'studyFirstSubmitQcDate': '2025-11-19', 'lastUpdatePostDateStruct': {'date': '2025-11-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-11-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2027-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Breast cancer-associated microbial signatures', 'timeFrame': '12 months', 'description': 'To characterize intratumoral microbial signatures (composition and inferred function) across breast cancer (BC) molecular subtypes (Luminal A, Luminal B, HER2-enriched, TNBC) using contamination-aware pipelines'}], 'secondaryOutcomes': [{'measure': 'Comparison of microbial signatures', 'timeFrame': '12 months', 'description': 'To compare microbial signatures between tumor and adjacent normal tissue (paired design)'}, {'measure': 'Association between microbial and host features', 'timeFrame': '12 months', 'description': 'To explore associations between intratumoral microbial features and clinicopathologic and host variables'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Breast Cancer']}, 'descriptionModule': {'briefSummary': 'Study on patients undergoing surgery for breast cancer. Objective: to characterize the intratumoral microbiota and integrate these findings with clinicopathologic data, the estrobolome, and gut microbiota, with analyses stratified by molecular subtype (Luminal A, Luminal B, HER2-enriched \\[human epidermal growth factor receptor 2-enriched\\], and TNBC \\[triple-negative breast cancer\\]).\n\nEnrollment: consecutive recruitment in the operating room based on the availability of biopsy/histological material.\n\nSamples: tumor tissue, adjacent normal tissue; urine (for indirect assessment of estrobolome activity); and stool. Strict anti-contamination measures will be implemented.\n\nExploratory outcomes: differences across subtypes, associations with features of the TME (tumor microenvironment), including TILs (tumor-infiltrating lymphocytes), and markers of progression or treatment resistance'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Women ≥18 years with primary, non-metastatic breast cancer (BC) undergoing surgery.\n* Availability of sufficient tumor and adjacent normal tissue for research purposes after completion of diagnostic sampling.\n* Written informed consent\n\nExclusion Criteria:\n\n* Active systemic infection or fever \\>38.0°C within 72 h pre-surgery.\n* Antibiotics within 14 days pre-sampling (recorded; analyses adjusted).\n* Prior ipsilateral BC surgery for current lesion (except re-excision with fresh tissue).\n* Any condition preventing compliance with the study protocol.'}, 'identificationModule': {'nctId': 'NCT07253168', 'acronym': 'TIGER-BC', 'briefTitle': 'Tumor Integrating Gut Microbiota in bREast Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Fondazione Policlinico Universitario Agostino Gemelli IRCCS'}, 'officialTitle': 'Intratumoral Microbiota in Breast Cancer: A Prospective Discovery Study Integrating Tumor/Adjacent Normal Tissue, Estrobolome, and Gut Microbiota Analyses, With Stratification by Molecular Subtypes', 'orgStudyIdInfo': {'id': '8051'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Patients undergoing surgery for breast cancer', 'description': 'single-arm discovery study with consecutive enrollment of eligible patients undergoing surgery for primary breast cancer', 'interventionNames': ['Procedure: Surgery for breast cancer']}], 'interventions': [{'name': 'Surgery for breast cancer', 'type': 'PROCEDURE', 'otherNames': ['Characterization of intratumoral microbiota'], 'description': 'To investigate the intratumoral microbiota in breast cancer and integrate these findings with gut microbiota analyses, including estrobolome characterization, to explore potential microbial-host interactions influencing tumor biology across molecular subtypes', 'armGroupLabels': ['Patients undergoing surgery for breast cancer']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Brunella Posteraro', 'role': 'CONTACT', 'email': 'brunella.posteraro@unicatt.it', 'phone': '+3906030157959'}], 'overallOfficials': [{'name': 'Brunella Posteraro', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Fondazione Policlinico Universitario A. Gemelli, IRCCS'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fondazione Policlinico Universitario Agostino Gemelli IRCCS', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}