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Accuracy of Sono-mammographic Features in Molecular Classification of Breast Cancer

Imaging-Pathologic Correlation of Breast Cancer: Mammographic and Sonographic Features in Relation to Molecular Classification

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07354490
Enrollment
122
Registered
2026-01-21
Start date
2026-01-20
Completion date
2028-01-01
Last updated
2026-01-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Brief summary

This study aims to evaluate the role of mammographic and sonographic features as non-invasive imaging tools in predicting the molecular subtypes of breast cancer, in correlation with histopathological findings.

Detailed description

Breast cancer is the most prevalent form of cancer among women. In the Middle East, it is the primary reason for cancer-related deaths among women Breast cancer has been classified into various histopathological and molecular subtypes based on its hormone receptor status. Their biological behaviour and prognosis depend on these hormonal subtypes. Based on gene expression patterns, breast cancer has been classified into five different molecular subtypes by the St. Gallen International Expert Consensus. They include: * Luminal A (LA). * Human epidermal growth factor receptor 2 (HER2) enriched. * Luminal B (LB) \[LB HER2-, LB HER2+\]. * Basal-like (triple-negative). The detection of these hormone receptors requires immunohistochemistry (IHC), which is an invasive, expensive method and may not be available in all centres, especially in less developed countries Hence, it is important to establish imaging signatures that can play an adjunct role in predicting these subtypes and assist in pre-treatment planning (4) Mammography (MG) and Ultrasound (US) are routinely used during breast cancer screening, and are commonly used to identify and characterise breast lesions and guide biopsy. Unlike breast MRI, these two modalities are virtually always and everywhere available at the time of cancer diagnosis. In this work, the investigators thus investigate the feasibility of predicting molecular subtypes of breast cancer from the combination of Mammography and Ultrasound.

Interventions

OTHERDiagnostic test: Ultrasound and Mammogram

Patients will receive digital bilateral mammography (craniocaudal and mediolateral oblique views) followed by high-resolution breast ultrasound using a linear transducer, performed by an experienced radiologist.

Sponsors

Assiut University
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

-The patients having BI-RADS IV, V, VI proven breast cancer.

Exclusion criteria

-Patients with post-neoadjuvant therapy and a prior history of breast cancer in the same breast with recurrence.

Design outcomes

Primary

MeasureTime frameDescription
Diagnostic performance of imaging features (Mammogram ,ultrasound ,and combined) for predicting molecular subtypes (Luminal A/B, HER2-enriched, TNBC)from imaging to histopathological confirmation (up to 2 weeks)The investigators will use mammographic and songraphic features encompassing morphology, margins, posterior echo, blood flow grading, and the presence or absence of calcification ,predict molecular subtypes, then compare it to the hispathological results.

Secondary

MeasureTime frame
-AUC, sensitivity, specificity, accuracy, PPV/NPV for each subtype. -Agreement between imaging-based classification and reference standard (histopathology + IHC): -Cohen's kappa (overall and per subtype).From imaging to histopathological and immunohistochemical confirmation (up to 2 weeks).

Contacts

CONTACTMai Abdelbaset Ahmed
Mai.17289680@med.aun.edu.eg+201094657457

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026