Ignite Creation Date:
2025-12-25 @ 1:28 AM
Ignite Modification Date:
2025-12-27 @ 5:42 AM
Study NCT ID:
NCT05680194
Status:
UNKNOWN
Last Update Posted:
2023-01-11
First Post:
2022-12-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prospective Research for Elderly (≥65 Years Old) Early Breast Cancer Patients
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'}, {'id': 'D004358', 'term': 'Drug Therapy'}, {'id': 'D011878', 'term': 'Radiotherapy'}, {'id': 'D004164', 'term': 'Diphosphonates'}], 'ancestors': [{'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D063065', 'term': 'Organophosphonates'}, {'id': 'D009943', 'term': 'Organophosphorus Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Paraffin section'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-06', 'completionDateStruct': {'date': '2025-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-12-26', 'studyFirstSubmitDate': '2022-12-19', 'studyFirstSubmitQcDate': '2022-12-26', 'lastUpdatePostDateStruct': {'date': '2023-01-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-01-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-03-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '5-y DFS', 'timeFrame': '5 year', 'description': '5-years of disease free survival'}, {'measure': '5-y BCSS', 'timeFrame': '5 year', 'description': '5-year of breast cancer-specific survival'}], 'secondaryOutcomes': [{'measure': '5-y OS', 'timeFrame': '5 year', 'description': '5-year overall survival'}, {'measure': '10-y DFS', 'timeFrame': '10 year', 'description': '10-years of disease free survival'}, {'measure': '10-y BCSS', 'timeFrame': '10 year', 'description': '10-year of breast cancer-specific survival'}, {'measure': '10-y OS', 'timeFrame': '10 year', 'description': '10-year overall survival'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['≥65 Years Old', 'early breast cancer'], 'conditions': ['Breast Cancer Female']}, 'descriptionModule': {'briefSummary': 'The elderly patients over 65 years old with breast cancer have concomitant diseases, poor tolerance to conventional treatment, and the specific prognosis of breast cancer is relatively good. Previous studies on breast cancer have almost excluded elderly breast cancer patients, and conventional treatment schemes cannot meet the clinical diagnosis and treatment needs of elderly breast cancer patients. The establishment of a prognosis model for elderly breast cancer patients can provide personalized treatment programs. This is important for prolonging the survival time of patients and improving the quality of life. This project plans to observe the relationship between prognosis and pathological staging, molecular typing, and concomitant diseases of elderly breast cancer patients in combination with immune genes, and establish a prognosis model of elderly breast cancer and verify it. This project is expected to establish a new prognostic model for elderly breast cancer patients, accurately judge the prognosis of patients, and provide a new basis for hierarchical and personalized treatment of elderly breast cancer.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '65 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'the patients ≥65 Years Old with breast cancer who received operaion in Peking Union Medical College Hospital', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* female patients with breast cancer\n* ≥65 Years Old\n* patients with breast cancer received operation in Peking Union Medical College Hospital\n* treatment regimen was made in Peking Union Medical College Hospital\n\nExclusion Criteria:\n\n* patients with metastasis\n* patietns with recurrence\n* patients without pathological information'}, 'identificationModule': {'nctId': 'NCT05680194', 'acronym': 'EEBC', 'briefTitle': 'Prospective Research for Elderly (≥65 Years Old) Early Breast Cancer Patients', 'organization': {'class': 'OTHER', 'fullName': 'Peking Union Medical College Hospital'}, 'officialTitle': 'Prospective Research for Elderly (≥65 Years Old) Early Breast Cancer Patients', 'orgStudyIdInfo': {'id': 'EEBC'}}, 'armsInterventionsModule': {'interventions': [{'name': 'operation', 'type': 'PROCEDURE', 'otherNames': ['chemotherapy', 'radiotherapy', 'endocrine therapy', 'targeted therapy'], 'description': 'operation methods: breast-conserving surgery, mastectomy, axillary lymph node dissection, sentinal lymphnodes biopsy; chemotherapy regimens: AC, TC, AC-T/P, TCrb, TAC, capecitabine; ovarian protection:GnRHa; endocrine therapy: Aromatase inhibitor, TAM, Fulvestrant, CDK4/6 inhibitors; target therapy: trastuzumab，patuzumab, Pyrotinib.'}, {'name': 'Bisphosphonate', 'type': 'DRUG', 'description': 'Bisphosphonate'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Beijing', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Ying Zhong', 'role': 'CONTACT', 'email': 'bakenfish@163.com', 'phone': '0086-01069158720'}], 'facility': 'Peking Union Medical College Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Ying Zhong', 'role': 'CONTACT', 'email': 'bakenfish@163.com', 'phone': '0086-01069158720'}, {'name': 'Xuefei Wang', 'role': 'CONTACT', 'email': '5574571@qq.com', 'phone': '0086-01069158720'}], 'overallOfficials': [{'name': 'Ying Zhong', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Peking Union Medical College Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Peking Union Medical College Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}