Correlation of Solitary Dilated Duct at Mammography With Ultrasonography and Anatomopathological Findings
NCT ID: NCT03161392
Last Updated: 2019-07-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
135 participants
OBSERVATIONAL
2016-03-16
2019-07-29
Brief Summary
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Detailed Description
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Methods: 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.
Patients 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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Ductal lesion
Subjects with a ductal lesion detected on ultrasonography.
Ultrasound-guided percutaneous biopsy
Group "Ductal lesion" will be submitted to ultrasound-guided percutaneous biopsy and the specimen will be histologically analysed.
No ductal lesion
Subjects without a ductal lesion detected on ultrasonography
Follow-up
Group "No ductal lesion" will be submitted to follow-up with periodic breast ultrasonography/mammography every 6 months for 2 years.
Interventions
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Follow-up
Group "No ductal lesion" will be submitted to follow-up with periodic breast ultrasonography/mammography every 6 months for 2 years.
Ultrasound-guided percutaneous biopsy
Group "Ductal lesion" will be submitted to ultrasound-guided percutaneous biopsy and the specimen will be histologically analysed.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
30 Years
90 Years
FEMALE
Yes
Sponsors
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Instituto Brasileiro de Controle do Cancer
OTHER
Faculdade de Medicina do ABC
OTHER
Responsible Party
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Luciano de Melo Pompei'
Professor
Principal Investigators
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Luciano M Pompei, PhD
Role: STUDY_DIRECTOR
ABC Medicine School
Other Identifiers
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Ductoisolado_01
Identifier Type: -
Identifier Source: org_study_id
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