NCT02815852

Brief Summary

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.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
210

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2016

Shorter than P25 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

First Submitted

Initial submission to the registry

June 24, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 28, 2016

Completed
5 months until next milestone

Study Start

First participant enrolled

December 1, 2016

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

February 8, 2024

Status Verified

December 1, 2017

Enrollment Period

1 year

First QC Date

June 24, 2016

Last Update Submit

February 7, 2024

Conditions

Keywords

breast cancer in women under 40 years oldbiopsyultrasonographyMagnetic Resonance Imaging

Outcome Measures

Primary Outcomes (1)

  • 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.

    It will be made a comparison between the radiological and histological reports of all patients with breast cancer diagnosis.

    September 2016

Secondary Outcomes (1)

  • 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

    September 2016

Interventions

Evaluation of 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.

Eligibility Criteria

AgeUp to 39 Years
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 24, 2016

First Posted

June 28, 2016

Study Start

December 1, 2016

Primary Completion

December 1, 2017

Study Completion

December 1, 2017

Last Updated

February 8, 2024

Record last verified: 2017-12