Evaluation of Solitary Dilated Duct Visualized by Mammography in Correlation With Ultrasonography and Anatomopathological Findings.

Correlation of Solitary Dilated Duct at Mammography With Ultrasonography and Anatomopathological Findings



Sponsors


Source

Faculdade de Medicina do ABC

Oversight Info

Has Dmc

No

Is Fda Regulated Drug

No

Is Fda Regulated Device

No


Brief Summary

Mammograms performed at the Diagnostic Imaging Department of the IBCC - Instituto Brasileiro
de Controle do Câncer (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 IBCC - Instituto
Brasileiro de Controle do Câncer (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 reconvocated 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.

Overall Status

Active, not recruiting

Start Date

2016-03-16

Completion Date

2019-03-13

Primary Completion Date

2017-03-13

Phase

N/A

Study Type

Observational

Primary Outcome

Measure

Time Frame

Abnormal histological finding at breast biopsy
At guided-percutaneous biopsy

Number Of Groups

2

Enrollment

135

Conditions


Intervention

Intervention Type

Diagnostic Test

Intervention Name


Description

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

Arm Group Label

No ductal lesion


Intervention Type

Diagnostic Test

Intervention Name


Description

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

Arm Group Label

Ductal lesion



Eligibility

Study Pop

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

Sampling Method

Non-Probability Sample

Criteria

Inclusion Criteria:

- Identification of a solitary dilated breast duct at mammography

Exclusion Criteria:

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

Gender

Female

Minimum Age

30 Years

Maximum Age

90 Years

Healthy Volunteers

Accepts Healthy Volunteers


Overall Official

Last Name

Role

Affiliation

Luciano M Pompei, PhD
Study Director
ABC Medicine School

Verification Date

2017-05-01

Lastchanged Date

2017-05-18

Firstreceived Date

2017-05-18

Responsible Party

Responsible Party Type

Principal Investigator

Investigator Affiliation

Faculdade de Medicina do ABC

Investigator Full Name

Luciano de Melo Pompei`

Investigator Title

Professor


Keywords


Has Expanded Access

No

Condition Browse


Arm Group

Arm Group Label

Ductal lesion

Description

Subjects with a ductal lesion detected on ultrassonography.


Arm Group Label

No ductal lesion

Description

Subjects without a ductal lesion detected on ultrassonography



Firstreceived Results Date

N/A

Patient Data

Sharing Ipd

No


Firstreceived Results Disposition Date

N/A

Study Design Info

Observational Model

Cohort

Time Perspective

Prospective



ClinicalTrials.gov processed this data on May 19, 2017

Conditions

Conditions usually refer to a disease, disorder, syndrome, illness, or injury. In ClinicalTrials.gov, conditions include any health issue worth studying, such as lifespan, quality of life, health risks, etc.
Interventions

Interventions refer to the drug, vaccine, procedure, device, or other potential treatment being studied. Interventions can also include less intrusive possibilities such as surveys, education, and interviews.
Study Phase

Most clinical trials are designated as phase 1, 2, 3, or 4, based on the type of questions that study is seeking to answer:

In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.

In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.

In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.

In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.

These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.



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