RETROSPECTIVE ANALYSIS OF BREAST BIOPSIES IN WOMEN YOUNGER THAN 40 YEARS OLD (RAD2016)

February 7, 2024 updated by: Azienda U.S.L. 1 di Massa e Carrara
The purpose of this study is to review retrospectively cases of breast cancer of the centers belonging to the BREST UNIT Tuscany North-West Wide Area and compare the imaging characteristics (ultrasound, mammography and mammary MRI if available) of breast cancer with the corresponding histological reports and assess whether in women <40 years the typical imaging presentation pattern of malignancies observed in women> 40 years are confirmed.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Breast cancer is the most frequent cancer in women and the leading cause of death in women under 50 years in the USA. In Italy, the Pool Airtum 2007-2010 figures confirm that breast cancer, excluding skin cancers, is 29% of cancers diagnosed in women and the leading cause of death in women, for the regions in which are active the cancer registries . Among women, breast cancer ranks first in all age groups: represents 29% of deaths in women aged <49 years, 23% in women between 50 and 69 years and 16% between women aged> 70 years. The disease is uncommon before age 30 but the European Cancer registries have detected since 1990 an increased incidence of breast cancer in women before age 40. For this reason it can be important to start to verify the incidence of breast cancer before age 40 in the BREAST UNIT of the Tuscany North-West Wide Area (Versilia, Lucca and Massa-Carrara). Mammography, which is the reference examination for prevention in women after age 40, has not shown before this age evidence of efficacy. Ultrasound examination, complementary to mammography, is generally well tolerated but did not demonstrate efficacy in prospective studies as a screening in reducing mortality. MRI with intravenous contrast medium is considered the exam with higher sensitivity in identifying neoplastic lesions especially in young women. This study therefore aims to review retrospectively cases of breast cancer of the centers belonging to the BREST UNIT Tuscany North-West Wide Area to locate a number of cases to allow for a comparison on the imaging characteristics (ultrasound, mammography and mammary MRI if available) of breast cancer and assess whether in women <40 years the typical imaging presentation pattern of malignancies observed in women> 40 years are confirmed. In this study will be involved pathological anatomy of the BREAST UNIT Tuscany North-West Wide Area (Massa-Carrara, Versilia, Lucca); Radiology (Massa-Carrara, Versilia, Lucca); Clinical breast surgery / oncology / radiology of the three USL (Massa-Carrara, Versilia, Lucca) of the Tuscany North-West Wide Area. Data of patients diagnosed with breast cancer from 01/01/2009 to 31/12/2015 will be collected starting in july 2016 and the publication of results will take place by December 2016.Risk factors, genetic mutations, receptors status, tumor stage, therapies for NHL / LH and previous breast tumors will be analyzed as well. The data will be stratified by: age (<30 years, 30-35 years and 35-39 years), biological parameters on histology, stage at diagnosis and imaging features. Patients undergoing breast biopsy sampling represent an already select group who may be susceptible to information bias inherent risk factors: to reduce this bias will recover all the information about the risk factors for breast cancer. 2) operator-dependent variability of ultrasound images: will be taken into account in the data analysis, as well as different machines used in the various hospitals and diversity of the reporting method. 3) The patients for which it will not be possible to correct analysis of the data will be excluded, but the selection bias of patients will still be taken into account in the analysis of the data.The statistical analysis will be done in 1 month, and the results will be published by December 2016.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
210

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

No older than 39 years (Child, Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Women aged <40 years with breast cancer diagnosis from 01/01/2009 to 31/12/2015 by imaging guided biopsy and / or histology of the surgical specimen extracted from the database of pathological anatomy afferent BREAST UNIT of Tuscany North-West Wide Area.

Description

Inclusion Criteria:

  • Women aged <40 years with breast cancer diagnosis from 01/01/2009 to 31/12/2015 by imaging guided biopsy and / or histology of the surgical specimen extracted from the database of pathological anatomy afferent BREAST UNIT of Tuscany North-West Wide Area.

Exclusion Criteria:

  • Women aged > 40 years with breast cancer diagnosis from 01/01/2009 to 31/12/2015 by imaging guided biopsy and / or histology of the surgical specimen extracted from the database of pathological anatomy afferent BREAST UNIT of Tuscany North-West Wide Area.
  • Women aged <40 years with breast cancer diagnosis before 01/01/2009 of after 31/12/2015 by imaging guided biopsy and / or histology of the surgical specimen extracted from the database of pathological anatomy afferent BREAST UNIT of Tuscany North-West Wide Area.
  • Patients with ultrasound examination and risk factors not available

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Compare the imaging features of benign and malignant mammary lesions in women <40 years with histological examinations to assess the correlatability between imaging morphology and histological characteristic of breast lesions.
Time Frame: September 2016
It will be made a comparison between the radiological and histological reports of all patients with breast cancer diagnosis.
September 2016

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Evaluate the incidence of malignant breast disease on total access to the Breast Unit of the Tuscany North-West Wide Area in patients <40 years
Time Frame: September 2016
September 2016

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Azienda U.S.L. 1 di Massa e Carrara

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 24, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 27, 2016

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 28, 2016

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 8, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 7, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Az.USLToscana Nord Ovest

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