Ignite Creation Date:
2025-12-24 @ 6:32 PM
Ignite Modification Date:
2025-12-29 @ 3:10 PM
Study NCT ID:
NCT05600257
Status:
COMPLETED
Last Update Posted:
2022-11-04
First Post:
2022-10-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Digital Breast Tomosynthesis in Breast Cancer Long-term Survival: a Single Institution Study
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': 'D008327', 'term': 'Mammography'}], 'ancestors': [{'id': 'D011859', 'term': 'Radiography'}, {'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1517}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-11', 'completionDateStruct': {'date': '2021-08-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-11-01', 'studyFirstSubmitDate': '2022-10-26', 'studyFirstSubmitQcDate': '2022-10-26', 'lastUpdatePostDateStruct': {'date': '2022-11-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-10-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-08-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall survival rate', 'timeFrame': 'Up to 111 months', 'description': 'Compare the overall survival rate according to breast density type, cancer stage, mammography test type, and imaging modality.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['breast cancer'], 'conditions': ['Breast Cancer']}, 'descriptionModule': {'briefSummary': 'To investigate whether digital breast tomosynthesis (DBT) benefits survival improvement.', 'detailedDescription': 'To suggest DBT for specific populations, compare the overall survival rate of women with digital mammography (DM) to the DBT screening for women with particular characteristics.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '89 Years', 'minimumAge': '23 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Individuals were diagnosed with breast cancer according to the International Disease Classification Criteria from September 2011 to December 2015.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* individuals were diagnosed with breast cancer according to the International Disease Classification Criteria\n\nExclusion Criteria:\n\n* no surgery or incomplete surgical pathology stage\n* complete remission after neoadjuvant chemotherapy\n* non-breast cancer death\n* bilateral breast cancer\n* male breast cancer\n* no pre-surgery mammography image'}, 'identificationModule': {'nctId': 'NCT05600257', 'briefTitle': 'The Effect of Digital Breast Tomosynthesis in Breast Cancer Long-term Survival: a Single Institution Study', 'organization': {'class': 'OTHER', 'fullName': 'Kaohsiung Veterans General Hospital.'}, 'officialTitle': 'The Effect of Digital Breast Tomosynthesis in Breast Cancer Long-term Survival: a Single Institution Study', 'orgStudyIdInfo': {'id': 'KSVGH22-CT11-01'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Screening cohort', 'description': 'Women received mammography screening', 'interventionNames': ['Device: DBT', 'Device: DM']}, {'label': 'Diagnostic cohort', 'description': 'Women received clinical breast examination', 'interventionNames': ['Device: DBT', 'Device: DM']}], 'interventions': [{'name': 'DBT', 'type': 'DEVICE', 'otherNames': ['Digital Breast Tomosynthesis'], 'description': 'Image with digital breast tomosynthesis', 'armGroupLabels': ['Diagnostic cohort', 'Screening cohort']}, {'name': 'DM', 'type': 'DEVICE', 'otherNames': ['Digital Mammography'], 'description': 'Image with digital mammography', 'armGroupLabels': ['Diagnostic cohort', 'Screening cohort']}]}, 'contactsLocationsModule': {'locations': [{'zip': '813', 'city': 'Kaohsiung City', 'country': 'Taiwan', 'facility': 'Kaohsiung Veterans General Hospital', 'geoPoint': {'lat': 22.61626, 'lon': 120.31333}}], 'overallOfficials': [{'name': 'Chen-Pin Chou, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Kaohsiung Veterans General Hospital.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'The data that support the findings of this study are available on reasonable request from the corresponding author. Some data are not publicly available due to their containing information that could compromise the privacy of research participants.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kaohsiung Veterans General Hospital.', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Radiologist', 'investigatorFullName': 'Chen-Pin Chou', 'investigatorAffiliation': 'Kaohsiung Veterans General Hospital.'}}}}