Ignite Creation Date:
2025-12-24 @ 10:46 PM
Ignite Modification Date:
2025-12-25 @ 8:16 PM
Study NCT ID:
NCT04429269
Status:
UNKNOWN
Last Update Posted:
2020-07-09
First Post:
2020-06-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Comparative Study of Mammography and Ultrasound for Breast Cancer Screening and Early Diagnosis
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'}]}, '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': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Biopsy or specimen from volunteers or donors are planned to be collected'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 6000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-06-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-07', 'completionDateStruct': {'date': '2023-06-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-07-07', 'studyFirstSubmitDate': '2020-06-10', 'studyFirstSubmitQcDate': '2020-06-10', 'lastUpdatePostDateStruct': {'date': '2020-07-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-06-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-06-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'screening yield', 'timeFrame': '3 years', 'description': 'The sensitivity, specificity, positive predictive value, and negative predictive value of the screening methods.'}], 'secondaryOutcomes': [{'measure': 'cost-effectiveness', 'timeFrame': '3 years', 'description': 'The cost-effectiveness of each screening modality to detect one case of breast cancer'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Mammography', 'ultrasound', 'breast cancer screening', 'early diagnosis'], 'conditions': ['Breast Cancer Diagnosis', 'Breast Cancer Screening']}, 'referencesModule': {'references': [{'pmid': '39715848', 'type': 'DERIVED', 'citation': 'Wang Y, Li Y, Qu Y, Zhou Y, Sun Q, Shen S. Clinical and imaging characteristics of intraductal papillary neoplasms of the breast: a prospective trial. Discov Oncol. 2024 Dec 23;15(1):831. doi: 10.1007/s12672-024-01681-y.'}, {'pmid': '36177910', 'type': 'DERIVED', 'citation': 'Wang Y, Li Y, Song Y, Chen C, Wang Z, Li L, Liu M, Liu G, Xu Y, Zhou Y, Sun Q, Shen S. Comparison of ultrasound and mammography for early diagnosis of breast cancer among Chinese women with suspected breast lesions: A prospective trial. Thorac Cancer. 2022 Nov;13(22):3145-3151. doi: 10.1111/1759-7714.14666. Epub 2022 Sep 30.'}]}, 'descriptionModule': {'briefSummary': 'Improving the early diagnosis of breast cancer can reduce mortality. With mammography as the main tool for screening early breast cancer, the characteristics of dense breast and young onset of disease in Chinese women lowers the efficiency. The aim of this prospective study was to compare which method, x-ray or ultrasound, is more appropriate for screening and early diagnosis of breast cancer in Chinese women.', 'detailedDescription': 'Breast cancer has become the most common malignancy in women. Improving the early diagnosis of breast cancer can reduce mortality. Mammography is recommended as the main tool for screening and early diagnosis of breast cancer in the guidelines of European and American countries. However, the characteristics of dense breast and young onset of disease in Chinese women make the screening and early diagnosis strategies of Western countries, which are mainly based on mammography, unsuitable for Chinese women. The aim of this prospective study was to compare which method, x-ray or ultrasound, is more appropriate for screening and early diagnosis of breast cancer in Chinese women.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '35 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Chinese female subjects aged 35-70 years who were asymptomatic and able to undergo ultrasound and X-rays', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Informed consent, subjects 35-70 years old, asymptomatic, able to undergo ultrasound and x-ray\n\nExclusion Criteria:\n\n* Localized breast erythema and ulceration, pregnancy, lactation, after previous breast implantation, already pathologically definite breast cancer patients'}, 'identificationModule': {'nctId': 'NCT04429269', 'acronym': 'MUSD', 'briefTitle': 'A Comparative Study of Mammography and Ultrasound for Breast Cancer Screening and Early Diagnosis', 'organization': {'class': 'OTHER', 'fullName': 'Peking Union Medical College Hospital'}, 'officialTitle': 'A Comparative Study of Mammography and Ultrasound for Breast Cancer Screening and Early Diagnosis', 'orgStudyIdInfo': {'id': 'PUMCH-MUSD'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'mammography and ultrasound', 'description': 'mammography and ultrasound screening', 'interventionNames': ['Diagnostic Test: mammography and ultrasound screening']}], 'interventions': [{'name': 'mammography and ultrasound screening', 'type': 'DIAGNOSTIC_TEST', 'description': 'Patients screened by both mammography and ultrasound.', 'armGroupLabels': ['mammography and ultrasound']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100730', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Songjie Shen, MD', 'role': 'CONTACT', 'email': 'shensj@pumch.cn', 'phone': '010 6915 8721'}], 'facility': 'Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Songjie Shen, MD', 'role': 'CONTACT', 'email': 'shensj@pumch.cn', 'phone': '(010) 6915 8721'}], 'overallOfficials': [{'name': 'Songjie Shen, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and PUMC, BJ, China'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Individual information of each participant of the trials is not shown in public, yet can be obtained upon reasonable requirements.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Peking Union Medical College Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}