Ignite Creation Date:
2025-12-25 @ 5:01 AM
Ignite Modification Date:
2025-12-26 @ 4:02 AM
Study NCT ID:
NCT04750018
Status:
UNKNOWN
Last Update Posted:
2021-02-11
First Post:
2021-02-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Influence of Co-Vid 19 Pandemic on Screening Mammography Single Institution
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086382', 'term': 'COVID-19'}, {'id': 'D001943', 'term': 'Breast Neoplasms'}], 'ancestors': [{'id': 'D011024', 'term': 'Pneumonia, Viral'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D018352', 'term': 'Coronavirus Infections'}, {'id': 'D003333', 'term': 'Coronaviridae Infections'}, {'id': 'D030341', 'term': 'Nidovirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 600}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-07-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-02', 'completionDateStruct': {'date': '2021-06-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-02-06', 'studyFirstSubmitDate': '2021-02-06', 'studyFirstSubmitQcDate': '2021-02-06', 'lastUpdatePostDateStruct': {'date': '2021-02-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-02-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-09-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'breast cancer', 'timeFrame': '1 year', 'description': 'Breast cancer or not'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['COVID-19', 'Breast Cancer'], 'conditions': ['COVID-19', 'Breast Cancer']}, 'referencesModule': {'references': [{'pmid': '32815587', 'type': 'RESULT', 'citation': 'Chou CP, Pan HB, Yang TL, Chiang CL, Huang JS, Tsai MY. Impact of the COVID-19 pandemic on the volume of mammography examinations in Southern Taiwan. Breast J. 2021 Jan;27(1):89-91. doi: 10.1111/tbj.14019. Epub 2020 Aug 20. No abstract available.'}, {'pmid': '34349563', 'type': 'DERIVED', 'citation': 'Chou CP, Lin HS. Delayed Breast Cancer Detection in an Asian Country (Taiwan) with Low COVID-19 Incidence. Cancer Manag Res. 2021 Jul 28;13:5899-5906. doi: 10.2147/CMAR.S314282. eCollection 2021.'}]}, 'descriptionModule': {'briefSummary': 'To assess whether the COVID-19 pandemic delayed breast cancer diagnosis in Taiwan, an Asian country with a low COVID-19 incidence.', 'detailedDescription': 'The institutional review board approved this retrospective study at a public academic medical center. The monthly volume of breast biopsies and breast cancers during the COVID-19 pandemic (between January 1 and July 31, 2020) was compared to the same period a year earlier (pre-COVID-19).'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '30 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': "The test period of the COVID-19 pandemic was between January 1 and July 31, 2020. Moreover, the control period of the pre-COVID-19 pandemic was between January 1 and July 31, 2019, before there was any report about the virus. Only patients with complete medical records were eligible for enrollment in this study. Confirmed COVID-19 case numbers in Taiwan were acquired from Taiwan's National Health Command Center \\[7\\]. Anonymized records of breast biopsies and cancer registration in a single institution in southern Taiwan in the pre-COVID-19 and COVID-19 periods were reviewed.", 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Receiving breast exam 2019-2020\n\nExclusion Criteria:\n\n* lost clinical follow-up'}, 'identificationModule': {'nctId': 'NCT04750018', 'briefTitle': 'Influence of Co-Vid 19 Pandemic on Screening Mammography Single Institution', 'organization': {'class': 'OTHER', 'fullName': 'Kaohsiung Veterans General Hospital.'}, 'officialTitle': 'Influence of Co-Vid 19 Pandemic on Screening Mammography in a Single Institution', 'orgStudyIdInfo': {'id': 'KSVGH20-CT7-26'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'COVID-19 2019', 'description': 'Patients receiving biopsies with a BI-RADS assessment of 4 or 5 from mammographic or ultrasonographic exams or combinations of tests were analyzed \\[4\\]. We further categorized the biopsy data as ultrasound-guided or mammograph-guided biopsy based on procedure coding. Ultrasound-guided core needle biopsy (CNB) was performed for breast lesions visible on ultrasound.'}, {'label': 'COVID-19 2020', 'description': 'Patients receiving biopsies with a BI-RADS assessment of 4 or 5 from mammographic or ultrasonographic exams or combinations of tests were analyzed \\[4\\]. We further categorized the biopsy data as ultrasound-guided or mammograph-guided biopsy based on procedure coding. Ultrasound-guided core needle biopsy (CNB) was performed for breast lesions visible on ultrasound.', 'interventionNames': ['Other: surgery']}], 'interventions': [{'name': 'surgery', 'type': 'OTHER', 'description': 'Patients were divided into surgery and no disease.', 'armGroupLabels': ['COVID-19 2020']}]}, 'contactsLocationsModule': {'locations': [{'zip': '813', 'city': 'Kaohsiung City', 'status': 'RECRUITING', 'country': 'Taiwan', 'facility': 'Radiology depart', 'geoPoint': {'lat': 22.61626, 'lon': 120.31333}}], 'centralContacts': [{'name': 'Chen-Pin Chou, MD', 'role': 'CONTACT', 'email': 'chouchenpin@gmail.com', 'phone': '*886-3422121', 'phoneExt': '6524'}], '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': 'Chen-Pin Chou', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Radiologist', 'investigatorFullName': 'Chen-Pin Chou', 'investigatorAffiliation': 'Kaohsiung Veterans General Hospital.'}}}}