NCT03161392

Brief 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. In case of detection of lesion, a percutaneous biopsy will be performed.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
135

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2016

Typical duration for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 16, 2016

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 13, 2017

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 18, 2017

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 19, 2017

Completed
2.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 29, 2019

Completed
Last Updated

July 30, 2019

Status Verified

July 1, 2019

Enrollment Period

12 months

First QC Date

May 18, 2017

Last Update Submit

July 29, 2019

Conditions

Mammary Duct Ectasia of Unspecified BreastMammographic FindingsFemale

Keywords

mammographyductal ectasiabreast neoplasm/diagnostic imagingmammary Glands, Human/pathologyfemale

Outcome Measures

Primary Outcomes (1)

  • Abnormal histological finding at breast biopsy

    Detection of any histological abnormality

    At guided-percutaneous biopsy

Study Arms (2)

Ductal lesion

Subjects with a ductal lesion detected on ultrasonography.

Diagnostic Test: Ultrasound-guided percutaneous biopsy

No ductal lesion

Subjects without a ductal lesion detected on ultrasonography

Diagnostic Test: Follow-up

Interventions

Follow-upDIAGNOSTIC_TEST

Group "No ductal lesion" will be submitted to follow-up with periodic breast ultrasonography/mammography every 6 months for 2 years.

No ductal lesion
Ultrasound-guided percutaneous biopsyDIAGNOSTIC_TEST

Group "Ductal lesion" will be submitted to ultrasound-guided percutaneous biopsy and the specimen will be histologically analysed.

Ductal lesion

Eligibility Criteria

Age30 Years - 90 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Women submitted to mammography for breast cancer screening or for diagnosis purposes

You may qualify if:

  • Identification of a solitary dilated breast duct at mammography

You may not qualify if:

  • Previous breast surgery at same side of detection of dilated duct

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Luciano M Pompei, PhD

    ABC Medicine School

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

May 18, 2017

First Posted

May 19, 2017

Study Start

March 16, 2016

Primary Completion

March 13, 2017

Study Completion

July 29, 2019

Last Updated

July 30, 2019

Record last verified: 2019-07

Data Sharing

IPD Sharing
Will not share