Ignite Creation Date:
2025-12-25 @ 3:04 AM
Ignite Modification Date:
2026-01-01 @ 3:46 AM
Study NCT ID:
NCT06773533
Status:
RECRUITING
Last Update Posted:
2025-01-14
First Post:
2024-12-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Registry of Adjuvant Hormone-blockade Breast Cancer Patients Evaluated for Bone Mineral Metabolism
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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 3000}, 'targetDuration': '10 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-12-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2039-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-01-13', 'studyFirstSubmitDate': '2024-12-03', 'studyFirstSubmitQcDate': '2025-01-13', 'lastUpdatePostDateStruct': {'date': '2025-01-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-01-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2029-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Establishment of a Registry for Patients Treated with Adjuvant Hormone Blockade for Breast Cancer: Evaluation of Bone Mass, Calcium Metabolism Indices, and Fracture Incidence', 'timeFrame': 'through study completion, an average of 15 years', 'description': 'Establishment of a registry by which to census all patients treated with adjuvant hormone blockade for previous breast cancer in order to evaluate in future studies the trend of bone mass and its relationship to laboratoristic indices inherent in calcium metabolism, and the prevalence and incidence of fractures.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Breast Cancer']}, 'descriptionModule': {'briefSummary': 'Establishment of a registry by which to census all patients treated with adjuvant hormone blockade for previous breast cancer in order to evaluate in future studies the trend of bone mass and its relationship to laboratoristic indices inherent in calcium metabolism, and the prevalence and incidence of fractures.', 'detailedDescription': "Establishment of a registry by which to census all patients treated with adjuvant hormone blockade for previous breast cancer in order to evaluate in future studies the trend of bone mass and its relationship to laboratoristic indices inherent in calcium metabolism, and the prevalence and incidence of fractures.\n\nInclusion in the registry will be proposed consecutively to every patient with adjuvant hormone-blockade breast cancer diagnosed and evaluated at the Endocrinology Operative Unit for Bone Mineral Metabolism as part of the 'Diagnostic Clinical-Assistance Pathway (PDTA) of the patient with breast cancer' of IRCCS AOU of Bologna and referred/referred by Zamagni Oncology. The registry will include patients seen from 01/01/2015 for a duration of 15 years. A maximum follow-up duration for each patient is expected to be 10 years with an end date of enrollment on 12/31/2029 and a registry update deadline on 12/31/2039."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "Each breast cancer patient on adjuvant hormone blockade diagnosed and evaluated at the Endocrinology Operative Unit for Bone Mineral Metabolism as part of the 'Diagnostic Clinical Care Pathway (PDTA) of the Breast Cancer Patient' of IRCCS AOU of Bologna and referred/referred by Zamagni Oncology.", 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥ 18 years\n* Patient undergoing adjuvant hormone blockade therapy (aromatase inhibitors, GnRH analogs, tamoxifen) for breast cancer referred by UO Oncology Zamagni\n* Performed densitometry at UO Radiology Lovato and performed hematochemical tests inherent to mineral metabolism\n* Informed consent obtained\n\nExclusion Criteria:\n\n* none'}, 'identificationModule': {'nctId': 'NCT06773533', 'briefTitle': 'Registry of Adjuvant Hormone-blockade Breast Cancer Patients Evaluated for Bone Mineral Metabolism', 'organization': {'class': 'OTHER', 'fullName': 'IRCCS Azienda Ospedaliero-Universitaria di Bologna'}, 'officialTitle': 'Establishment of a Registry of Adjuvant Hormone-blockade Breast Cancer Patients Evaluated for Bone Mineral Metabolism', 'orgStudyIdInfo': {'id': 'Als-BONE'}}, 'contactsLocationsModule': {'locations': [{'zip': '40138', 'city': 'Bologna', 'state': 'Bologna', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Uberto Pagotto, MD', 'role': 'CONTACT', 'email': 'uberto.pagotto@unibo.it', 'phone': '+390512144190'}, {'name': 'Uberto Pagotto, MD', 'role': 'CONTACT'}], 'facility': 'IRCCS Azienda Ospedaliero-Universitaria di Bologna', 'geoPoint': {'lat': 44.49381, 'lon': 11.33875}}], 'centralContacts': [{'name': 'Uberto Pagotto, MD', 'role': 'CONTACT', 'email': 'uberto.pagotto@unibo.it', 'phone': '+390512144190'}], 'overallOfficials': [{'name': 'Uberto Pagotto, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'IRCCS Azienda Ospedaliero-Universitaria di Bologna'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'IRCCS Azienda Ospedaliero-Universitaria di Bologna', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}