Ignite Creation Date:
2025-12-24 @ 3:21 PM
Ignite Modification Date:
2026-03-11 @ 11:21 AM
Study NCT ID:
NCT03161392
Status:
COMPLETED
Last Update Posted:
2019-07-30
First Post:
2017-05-18
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Correlation of Solitary Dilated Duct at Mammography With Ultrasonography and Anatomopathological Findings
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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 135}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-03-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-07', 'completionDateStruct': {'date': '2019-07-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-07-29', 'studyFirstSubmitDate': '2017-05-18', 'studyFirstSubmitQcDate': '2017-05-18', 'lastUpdatePostDateStruct': {'date': '2019-07-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-05-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-03-13', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Abnormal histological finding at breast biopsy', 'timeFrame': 'At guided-percutaneous biopsy', 'description': 'Detection of any histological abnormality'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['mammography', 'ductal ectasia', 'breast neoplasm/diagnostic imaging', 'mammary Glands, Human/pathology', 'female'], 'conditions': ['Mammary Duct Ectasia of Unspecified Breast', 'Mammographic Findings', 'Female']}, 'descriptionModule': {'briefSummary': 'Mammograms performed at the Diagnostic Imaging Department of the "Instituto Brasileiro de Controle do Câncer" (IBCC - Brazilian Cancer Control Institute) will be prospectively evaluated. Patients who present a solitary dilated duct visualized by mammography will be submitted to breast ultrasonography. In case of detection of lesion, a percutaneous biopsy will be performed.', 'detailedDescription': 'Purpose: To determinate the incidence, pathological significance and risk factors associated with the presence of solitary dilated duct visualized at mammography exam.\n\nMethods: Mammograms performed at the Diagnostic Imaging Department of the "Instituto Brasileiro de Controle do Câncer" (IBCC - Brazilian Cancer Control Institute) will be prospectively evaluated. Patients who present a solitary dilated duct visualized by mammography will be included in the study. These patients will be recalled in order to be submitted to an ultrasonography directed to the mammographic finding. Patients who present lesions on ultrasonography will undergo method-guided percutaneous biopsy.\n\nPatients with ductal ectasia, without evident lesions, will be followed for 2 years to evaluate stability by means of mammography or ultrasonography every 6-month intervals.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '30 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Women submitted to mammography for breast cancer screening or for diagnosis purposes', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Identification of a solitary dilated breast duct at mammography\n\nExclusion Criteria:\n\n* Previous breast surgery at same side of detection of dilated duct'}, 'identificationModule': {'nctId': 'NCT03161392', 'briefTitle': 'Correlation of Solitary Dilated Duct at Mammography With Ultrasonography and Anatomopathological Findings', 'organization': {'class': 'OTHER', 'fullName': 'Faculdade de Medicina do ABC'}, 'officialTitle': 'Evaluation of Solitary Dilated Duct Visualized by Mammography in Correlation With Ultrasonography and Anatomopathological Findings.', 'orgStudyIdInfo': {'id': 'Ductoisolado_01'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Ductal lesion', 'description': 'Subjects with a ductal lesion detected on ultrasonography.', 'interventionNames': ['Diagnostic Test: Ultrasound-guided percutaneous biopsy']}, {'label': 'No ductal lesion', 'description': 'Subjects without a ductal lesion detected on ultrasonography', 'interventionNames': ['Diagnostic Test: Follow-up']}], 'interventions': [{'name': 'Follow-up', 'type': 'DIAGNOSTIC_TEST', 'description': 'Group "No ductal lesion" will be submitted to follow-up with periodic breast ultrasonography/mammography every 6 months for 2 years.', 'armGroupLabels': ['No ductal lesion']}, {'name': 'Ultrasound-guided percutaneous biopsy', 'type': 'DIAGNOSTIC_TEST', 'description': 'Group "Ductal lesion" will be submitted to ultrasound-guided percutaneous biopsy and the specimen will be histologically analysed.', 'armGroupLabels': ['Ductal lesion']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Luciano M Pompei, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'ABC Medicine School'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Faculdade de Medicina do ABC', 'class': 'OTHER'}, 'collaborators': [{'name': 'Instituto Brasileiro de Controle do Cancer', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': "Luciano de Melo Pompei'", 'investigatorAffiliation': 'Faculdade de Medicina do ABC'}}}}