RecruitingNCT07415499

Breast Density Impact on Mammographic Screening for Breast Cancer Diagnosis

Retrospective Study on Patients Undergoing Mammographic Screening to Evaluate the Impact of Breast Density on Breast Cancer Diagnosis


Sponsor

Azienda Sanitaria Locale CN2 Alba-Bra

Enrollment

3,300 participants

Start Date

Jan 12, 2026

Study Type

OBSERVATIONAL

Conditions

Summary

This retrospective, observational study aims to evaluate how breast density affects the accuracy and outcomes of mammographic screening for breast cancer within the regional screening program "Prevenzione Serena". Breast density is an important factor because dense breast tissue can make it more difficult to detect breast cancer on a mammogram. Dense tissue and tumors both appear white on a mammogram, which may hide abnormalities and lead to missed cancers or false-positive results. Women aged 45 to 75 years who underwent routine mammographic screening at ASL CN2 between September 2023 and May 2024 will be included. Breast density will be classified using the BI-RADS system (categories A-D), and the study will assess whether women with dense breasts (categories C and D) experience higher rates of recalls for second-level examinations such as ultrasound, MRI, etc). The study also includes an internal validation of Insight BD, an automated breast-density measurement software used at ASL CN2. The software will be evaluated using a mammography phantom (to verify technical accuracy) and by comparing its BI-RADS density classifications with readings from two radiologists (one expert and one less experienced). This will help determine whether the software can support radiologists, especially in evaluating dense breast tissue. Additional factors such as menopausal status, family history of breast cancer, and hormone therapy will also be examined to understand how they relate to breast density and screening outcomes. The study aims to quantify the frequency of false-positive recalls-cases in which additional tests are recommended but cancer is not found-because these events can increase patient anxiety and healthcare workload. Ultimately, this research seeks to provide evidence that may inform future screening guidelines and support more personalized approaches, particularly for women with dense breasts.


Eligibility

Sex: FEMALEMin Age: 45 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study examines how breast density affects the ability of mammography screening to detect breast cancer. Dense breast tissue can make it harder to spot tumors on a mammogram. Researchers will analyze data from women who participated in a mammography screening program to better understand this relationship. **You may be eligible if...** - You are a woman aged 45 to 75 years - You participated in the Prevenzione Serena mammography screening program between September 2023 and May 2024 at ASL CN2 in Italy - You have signed informed consent **You may NOT be eligible if...** - You do not meet the program participation criteria Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERNo intervention is administered.

No intervention is administered.


Locations(1)

SSD Fisica Sanitaria - Ospedale Michele e Pietro Ferrero di Verduno (CN) - ASL CN2

Verduno, Italy/CN, Italy

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NCT07415499


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