Clinical trial · Observational
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
NCT07354490CI-TRIAL-00101344not yet recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Diagnostic test: Ultrasound and Mammogram | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Diagnostic performance of imaging features (Mammogram ,ultrasound ,and combined) for predicting molecular subtypes (Luminal A/B, HER2-enriched, TNBC)
- timeFrame
- from imaging to histopathological confirmation (up to 2 weeks)
- description
- 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 outcomes (1)
- measure
- -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).
- timeFrame
- From imaging to histopathological and immunohistochemical confirmation (up to 2 weeks).
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (1)
- BACKGROUNDShaikh 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