Ignite Creation Date:
2025-12-24 @ 12:58 PM
Ignite Modification Date:
2025-12-29 @ 6:28 PM
Study NCT ID:
NCT06970561
Status:
COMPLETED
Last Update Posted:
2025-05-14
First Post:
2025-05-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Analysis of Recurrence of Intraductal Papilloma Treated With Vacuum-assisted Rotary Excision
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 106}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-01-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2024-09-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-05-13', 'studyFirstSubmitDate': '2025-05-04', 'studyFirstSubmitQcDate': '2025-05-13', 'lastUpdatePostDateStruct': {'date': '2025-05-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-05-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-08-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'recurrence', 'timeFrame': 'The cut-off date for follow-up was September 2024', 'description': 'Recurrence was defined as the appearance of a lesion within 2-3 cm of the original surgical area with corresponding clinical manifestations, such as nipple discharge and imaging support, which was later pathologically confirmed as IDP'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['intraductal papilloma of the breast', 'treatment', 'vacuum-assisted rotational excision therapy'], 'conditions': ['Breast Cancer Surgery', 'Benign Breast Tumors']}, 'descriptionModule': {'briefSummary': 'To study the postoperative recurrence of intraductal papillomas (IDP) treated with ultrasound-guided vacuum-assisted excision (VAE), and to investigate the effect of different lesion characteristics on recurrence.', 'detailedDescription': '106 patients with IDP with or without atypical ductal hyperplasia (ADH) treated with ultrasound-guided VAE at Zhongnan Hospital of Wuhan University from January 2020 to August 2024 were selected for the study, and the postoperative conditions of the patients were sorted out and followed up to analyze the characteristics of the lesions and to determine the relevant factors that affected the postoperative recurrence.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'IDP patients who underwent ultrasound-guided VAE treatment from January 2020 to August 2024 in Zhongnan Hospital of Wu han University.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* IDP was diagnosed pathologically after VAE treatment\n* the tumor was a solitary lesion with the margin \\>1cm from the nipple and the longest diameter of the tumor \\<3cm\n* it was not associated with other breast diseases\n\nExclusion Criteria:\n\n* previous ductal breast surgery\n* abnormal coagulation function or taking anticoagulant drugs .recent or current use of hormonal or psychotropic drugs.'}, 'identificationModule': {'nctId': 'NCT06970561', 'acronym': 'IDP', 'briefTitle': 'Analysis of Recurrence of Intraductal Papilloma Treated With Vacuum-assisted Rotary Excision', 'organization': {'class': 'OTHER', 'fullName': "Wuhan Children's Hospital"}, 'officialTitle': 'Analysis of Factors Associated With Postoperative Recurrence of Intraductal Papilloma of the Breast Treated With Ultrasound-guided Vacuum-assisted Rotary Excision', 'orgStudyIdInfo': {'id': '2020091'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'recurrent', 'description': 'Patients who relapsed after receiving ultrasound-guided vacuum-assisted rotary excision', 'interventionNames': ['Procedure: enlarged resection']}, {'label': 'non-recurrent', 'description': 'Patients who did not relapsed after receiving ultrasound-guided vacuum-assisted rotary excision'}], 'interventions': [{'name': 'enlarged resection', 'type': 'PROCEDURE', 'otherNames': ['secondary enlarged resection'], 'description': 'patients underwent secondary enlarged resection within 1 month after the diagnosis of IDP combined with ADH,', 'armGroupLabels': ['recurrent']}]}, 'contactsLocationsModule': {'locations': [{'zip': '430016', 'city': 'Wuhan', 'state': 'Hubei', 'country': 'China', 'facility': 'Zhongnan Hospital of Wuhan University', 'geoPoint': {'lat': 30.58333, 'lon': 114.26667}}]}, 'ipdSharingStatementModule': {'infoTypes': ['CSR'], 'timeFrame': 'starting 6 months after publication', 'ipdSharing': 'YES', 'description': 'all collected IPD, all IPD that underlie results in a publication', 'accessCriteria': 'The IPD can be shared for the summary report of test results,the reanalysis of test data and enables the combination of test data with other data for new research.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Wuhan Children's Hospital", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Attending physician，Thyroid and breast surgery', 'investigatorFullName': 'Gang Hu', 'investigatorAffiliation': "Wuhan Children's Hospital"}}}}