RETROSPECTIVE ANALYSIS OF BREAST BIOPSIES IN WOMEN YOUNGER THAN 40 YEARS OLD
RAD2016
1 other identifier
observational
210
0 countries
N/A
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Dec 2016
Shorter than P25 for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 24, 2016
CompletedFirst Posted
Study publicly available on registry
June 28, 2016
CompletedStudy Start
First participant enrolled
December 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2017
CompletedFebruary 8, 2024
December 1, 2017
1 year
June 24, 2016
February 7, 2024
Conditions
Keywords
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
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