Ignite Creation Date:
2025-12-24 @ 6:28 PM
Ignite Modification Date:
2026-01-25 @ 5:44 AM
Study NCT ID:
NCT06544668
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-08-09
First Post:
2024-08-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study for Dynamic Prediction Model of Breast Cancer Bone Metastases
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': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 3500}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-08-06', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2025-01-20', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-08-05', 'studyFirstSubmitDate': '2024-08-05', 'studyFirstSubmitQcDate': '2024-08-05', 'lastUpdatePostDateStruct': {'date': '2024-08-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-08-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-01-20', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To identify the risk factors and develop a prediction model for bone metastasis in breast cancer patients', 'timeFrame': '60 months', 'description': 'The correlation between clinical characteristics and bone metastasis, and the accuracy of prediction model'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Breast Cancer', 'Bone Metastases']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to identify the risk factors of bone metastasis in breast cancer patients so as to develop a dynamic prediction model using real world clinical data. The multicenter data will be retrospectively collected, and the clinical characteristics related to bone metastasis will be analyzed.', 'detailedDescription': 'Breast cancer is the most common malignant tumor in women worldwide and bones are the most common sites of metastases in breast cancer patients(\\~70%). Bone metastasis often leads to skeletal-related events (SREs) ,which may not only reduce the quality of life in patients, but also affect the long-term survival. Therefore, early detection and early intervention of bone metastasis are particularly important for breast cancer patients.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '20 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': '3500 breast cancer patients diagnosed between 2010 and 2020.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients diagnosed with breast cancer by histopathology;\n2. Age between 20 and 70 years old;\n3. The first diagnosis time is between 2010 and 2020;\n4. Complete diagnosis and treatment information, including basic information, breast cancer diagnosis, surgery, recurrence diagnosis data (including the diagnosis of the metastasis sites), anti-tumor treatment data, bone health and bone metastasis-related diagnosis and treatment data, etc.;\n5. Sufficient available follow-up information.\n\nExclusion Criteria:\n\n1. Missing important basic information (including initial and recurrent pathology, stage, pathological grade and time, surgery time, and drug treatment);\n2. With distant metastasis at the initial diagnosis;\n3. Patients with autoimmune diseases or aggressive viral infections (such as HIV or hepatitis);\n4. Other malignant tumors;\n5. Unclear information about distant metastasis.'}, 'identificationModule': {'nctId': 'NCT06544668', 'briefTitle': 'A Study for Dynamic Prediction Model of Breast Cancer Bone Metastases', 'organization': {'class': 'OTHER', 'fullName': 'Cancer Institute and Hospital, Chinese Academy of Medical Sciences'}, 'officialTitle': 'A Clinical Study to Establish a Dynamic Prediction Model for Bone Metastases Based on Breast Cancer Real-world Data', 'orgStudyIdInfo': {'id': 'NCC4673'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Breast cancer patients with bone metastasis', 'interventionNames': ['Other: Breast cancer patients with bone metastasis']}, {'label': 'Breast cancer patients without bone metastasis', 'interventionNames': ['Other: Breast cancer patients without bone metastasis']}], 'interventions': [{'name': 'Breast cancer patients with bone metastasis', 'type': 'OTHER', 'description': 'This study is an observational study', 'armGroupLabels': ['Breast cancer patients with bone metastasis']}, {'name': 'Breast cancer patients without bone metastasis', 'type': 'OTHER', 'description': 'This study is an observational study', 'armGroupLabels': ['Breast cancer patients without bone metastasis']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100021', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cancer Institute and Hospital, Chinese Academy of Medical Sciences', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Chief physician', 'investigatorFullName': 'Ma Fei，MD', 'investigatorAffiliation': 'Cancer Institute and Hospital, Chinese Academy of Medical Sciences'}}}}