Ignite Creation Date:
2025-12-24 @ 10:52 PM
Ignite Modification Date:
2026-02-20 @ 6:42 PM
Study NCT ID:
NCT02493569
Status:
UNKNOWN
Last Update Posted:
2016-08-10
First Post:
2015-07-07
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Multicenter Study of Clinical Epidemiology of Breast Cancer in Shaanxi Province of China
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}, {'id': 'D004194', 'term': 'Disease'}], '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'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'ECOLOGIC_OR_COMMUNITY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 3000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2016-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-08', 'lastUpdateSubmitDate': '2016-08-09', 'studyFirstSubmitDate': '2015-07-07', 'studyFirstSubmitQcDate': '2015-07-07', 'lastUpdatePostDateStruct': {'date': '2016-08-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-07-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall five-year survival for the female breast cancer patients', 'timeFrame': '5 years'}]}, 'conditionsModule': {'keywords': ['Breast cancer, hospital, epidemiology, diagnosis, treatment'], 'conditions': ['Breast Cancer']}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to study the epidemic features and diagnosis of female breast cancer, especially the diagnosis and treatment of breast cancer.The disease-free survival (DFS) and the total survival time(OS) of the breast cancer patients will also be studied.', 'detailedDescription': 'The study is a multicentric, retrospective clinical study based on the hospital. The target number of cases are X patients who are eligible for breast cancer after radical mastectomy. To collect the clinicopathological data and treatment data of the breast cancer patients and do the follow-up visit of all the patients who are included in the study.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The female breast cancer patients in Shaanxi Province of China, those study population shoud be the hospitalized patients who are confirmed of the primary breast cancer histologically, moreover, the date of the inpatients are within the month we chosen and those inpatients should have been received or under receiving the relevant treatment including surgical treatment, chemotherapy and radiotherapy.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Female patients;\n* The hospitalized patients who are confirmed of the primary breast cancer histologically;\n* The date of the inpatients are within the month we chosen;\n* Patients who are within the month we chosen have been received or under receiving the relevant treatment including surgical treatment, chemotherapy and radiotherapy.\n\nExclusion Criteria:\n\n* Male breast cancer patients;\n* Patients with breast cancer who are not under the chosen time;\n* Non hospitalized patients.'}, 'identificationModule': {'nctId': 'NCT02493569', 'briefTitle': 'A Multicenter Study of Clinical Epidemiology of Breast Cancer in Shaanxi Province of China', 'organization': {'class': 'OTHER', 'fullName': "First Affiliated Hospital Xi'an Jiaotong University"}, 'officialTitle': 'A Multicenter Study of Clinical Epidemiology of Breast Cancer in Shaanxi Province of China (Based on Hospital)', 'orgStudyIdInfo': {'id': 'KYLLSL-2015-153-01'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Epidemiology breast cancer patients', 'description': 'Observe the features of clinical diagnosis and treatment for female breast cancer patients', 'interventionNames': ['Procedure: The radical mastectomy of breast cancer']}], 'interventions': [{'name': 'The radical mastectomy of breast cancer', 'type': 'PROCEDURE', 'description': 'The radical mastectomy of breast cancer could be used for the treatment of breast cancer during the observation.', 'armGroupLabels': ['Epidemiology breast cancer patients']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Yu Ren, MD,PhD', 'role': 'CONTACT', 'email': 'renyyyyy@126.com', 'phone': '13700222161'}], 'overallOfficials': [{'name': 'Yu Ren, MD,PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "First Affiliated Hospital Xi'an Jiaotong University"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "First Affiliated Hospital Xi'an Jiaotong University", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}