Accuracy of Sono-mammographic Features in Molecular Classification of Breast Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Diagnostic test: Ultrasound and Mammogram.
- Who it may be relevant to
- Registry conditions: Breast Cancer. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Imaging-Pathologic Correlation of Breast Cancer: Mammographic and Sonographic Features in Relation to Molecular Classification
Overview
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
- Other Diagnostic 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.
Primary outcome measures
- Diagnostic performance of imaging features (Mammogram ,ultrasound ,and combined) for predicting molecular subtypes (Luminal A/B, HER2-enriched, TNBC) [Time frame: from imaging to histopathological confirmation (up to 2 weeks)]
Secondary outcome measures (1)
- -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). [Time frame: From imaging to histopathological and immunohistochemical confirmation (up to 2 weeks).]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Other
Study locations
Center list to be confirmed — check the primary protocol.
Publications
- Shaikh S, Rasheed A. Predicting Molecular Subtypes of Breast Cancer with Mammography and Ultrasound Findings: Introduction of Sono-Mammometry Score. Radiol Res Pract. 2021 Feb 9;2021:6691958. doi: 10.1155/2021/6691958. eCollection 2021. PMID 33628504
Identifiers
NCT: NCT07354490 · sono& mammo in breast cancer