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
1 other identifier
observational
122
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jan 2026
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
January 9, 2026
CompletedStudy Start
First participant enrolled
January 20, 2026
CompletedFirst Posted
Study publicly available on registry
January 21, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
January 1, 2028
January 21, 2026
January 1, 2026
1.4 years
January 9, 2026
January 15, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Diagnostic performance of imaging features (Mammogram ,ultrasound ,and combined) for predicting molecular subtypes (Luminal A/B, HER2-enriched, TNBC)
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.
from imaging to histopathological confirmation (up to 2 weeks)
Secondary Outcomes (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).
From imaging to histopathological and immunohistochemical confirmation (up to 2 weeks).
Interventions
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.
Eligibility Criteria
The study population consists of 122 women aged 18 years and older with suspected breast lesions referred for diagnostic breast ultrasound and mammography with histopathological confirmation.
You may qualify if:
- The patients having BI-RADS IV, V, VI proven breast cancer.
You may not qualify if:
- Patients with post-neoadjuvant therapy and a prior history of breast cancer in the same breast with recurrence.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
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: 33628504BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Dr
Study Record Dates
First Submitted
January 9, 2026
First Posted
January 21, 2026
Study Start
January 20, 2026
Primary Completion (Estimated)
July 1, 2027
Study Completion (Estimated)
January 1, 2028
Last Updated
January 21, 2026
Record last verified: 2026-01