Mammary Duct Ectasia of Unspecified BreastNCT03161392
Correlation of Solitary Dilated Duct at Mammography With Ultrasonography and Anatomopathological Findings
An observational study of Mammary Duct Ectasia of Unspecified Breast and Mammographic Findings, run by Faculdade de Medicina do ABC.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 30 to 90 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Mammary Duct Ectasia of Unspecified Breast, Mammographic Findings, Female
- What is being tested?
- Follow-up and Ultrasound-guided percutaneous biopsy
- How many people
- 135 participants
- Where
- No sites listed yet
- Study dates
- 16 Mar 2016to 29 Jul 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 90 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Women submitted to mammography for breast cancer screening or for diagnosis purposes
Who may be able to join
- Identification of a solitary dilated breast duct at mammography
Who cannot join
- Previous breast surgery at same side of detection of dilated duct
About this study
Official title: Evaluation of Solitary Dilated Duct Visualized by Mammography in Correlation With Ultrasonography and Anatomopathological Findings.
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.
Read the detailed description
Purpose: To determinate the incidence, pathological significance and risk factors associated with the presence of solitary dilated duct visualized at mammography exam.
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.
- Being tested
- Follow-up, Ultrasound-guided percutaneous biopsy
- Keywords
- mammography, ductal ectasia, breast neoplasm/diagnostic imaging, mammary Glands, Human/pathology, female
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Follow-upDiagnostic test
Group "No ductal lesion" will be submitted to follow-up with periodic breast ultrasonography/mammography every 6 months for 2 years.
Ultrasound-guided percutaneous biopsyDiagnostic test
Group "Ductal lesion" will be submitted to ultrasound-guided percutaneous biopsy and the specimen will be histologically analysed.
| Study group | Role | What they receive |
|---|---|---|
| Ductal lesion | Subjects with a ductal lesion detected on ultrasonography. Receives: Diagnostic Test: Ultrasound-guided percutaneous biopsy | |
| No ductal lesion | Subjects without a ductal lesion detected on ultrasonography Receives: Diagnostic Test: Follow-up |
What is being measured
The primary outcome is the main question the study is designed to answer.
Abnormal histological finding at breast biopsy
Detection of any histological abnormality
Measured: At guided-percutaneous biopsy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2017
- Study start16 Mar 2016
- Primary completion13 Mar 2017
- Study completion29 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mammary Duct Ectasia of Unspecified BreastStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 135 participants (actual)
Sponsor and investigators
- Lead sponsor
- Faculdade de Medicina do ABC
- Sponsor type
- University, hospital or other
- Collaborators
- Instituto Brasileiro de Controle do Cancer
- Responsible party
- Principal investigator, Luciano de Melo Pompei', Faculdade de Medicina do ABC
- Investigators
- Luciano M Pompei, PhD, Study director, ABC Medicine School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03161392
- Sponsor's protocol ID
- Ductoisolado_01
- Status last verified
- Jul 2019
- First submitted
- 18 May 2017
- Last updated
- 30 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Solitary Dilated Duct Visualized by Mammography in Correlation With Ultrasonography and Anatomopathological Findings.
- ClinicalTrials.gov ID
- NCT03161392
- Acronym / sponsor ID
- Ductoisolado_01
- Keywords
- mammography, ductal ectasia, breast neoplasm/diagnostic imaging, mammary Glands, Human/pathology, female
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 135 participants (actual)
- Lead sponsor
- Faculdade de Medicina do ABCUniversity, hospital or other
- Collaborators
- Instituto Brasileiro de Controle do Cancer
- Study start
- 16 Mar 2016 (actual)
- Primary completion
- 13 Mar 2017 (actual)
- Study completion
- 29 Jul 2019 (actual)
- First posted
- 19 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Purpose: To determinate the incidence, pathological significance and risk factors associated with the presence of solitary dilated duct visualized at mammography exam.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ductal lesion | – | Diagnostic Test: Ultrasound-guided percutaneous biopsySubjects with a ductal lesion detected on ultrasonography. |
| No ductal lesion | – | Diagnostic Test: Follow-upSubjects without a ductal lesion detected on ultrasonography |
Who may qualify
- Ages
- 30 to 90 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Women submitted to mammography for breast cancer screening or for diagnosis purposes
Key inclusion criteria (1 listed)
- Identification of a solitary dilated breast duct at mammography
Key exclusion criteria (1 listed)
- Previous breast surgery at same side of detection of dilated duct
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Follow-upGroup "No ductal lesion" will be submitted to follow-up with periodic breast ultrasonography/mammography every 6 months for 2 years. | Diagnostic test | No ductal lesion |
| Ultrasound-guided percutaneous biopsyGroup "Ductal lesion" will be submitted to ultrasound-guided percutaneous biopsy and the specimen will be histologically analysed. | Diagnostic test | Ductal lesion |
Primary outcome
Abnormal histological finding at breast biopsy
Time frame: At guided-percutaneous biopsy
Detection of any histological abnormality
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2019.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Luciano M Pompei, PhD study director
ABC Medicine School
Questions about this trial
What is this clinical trial studying?
An observational study of Mammary Duct Ectasia of Unspecified Breast and Mammographic Findings, run by Faculdade de Medicina do ABC.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Abnormal histological finding at breast biopsy (time frame: At guided-percutaneous biopsy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2019.