Breast CancerNCT07354490
Accuracy of Sono-mammographic Features in Molecular Classification of Breast Cancer
An observational study of Breast Cancer, run by Assiut University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Diagnostic test: Ultrasound and Mammogram
- How many people
- 122 participants
- Where
- No sites listed yet
- Study dates
- 20 Jan 2026to Jan 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- -The patients having BI-RADS IV, V, VI proven breast cancer.
Who cannot join
- -Patients with post-neoadjuvant therapy and a prior history of breast cancer in the same breast with recurrence.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Imaging-Pathologic Correlation of Breast Cancer: Mammographic and Sonographic Features in Relation to Molecular Classification
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.
Read the 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.
- Conditions
- Breast Cancer
- Being tested
- Diagnostic test: Ultrasound and Mammogram
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diagnostic test: Ultrasound and MammogramOther
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: From imaging to histopathological and immunohistochemical confirmation (up to 2 weeks).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2026
- Study start20 Jan 2026 (estimated)
- Primary completionJul 2027 (estimated)
- Study completionJan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 122 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mai Abdelbaset Ahmed Elshahir Attia Taha, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07354490
- Sponsor's protocol ID
- sono& mammo in breast cancer
- Status last verified
- Jan 2026
- First submitted
- 9 Jan 2026
- Last updated
- 21 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 33628504
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Imaging-Pathologic Correlation of Breast Cancer: Mammographic and Sonographic Features in Relation to Molecular Classification
- ClinicalTrials.gov ID
- NCT07354490
- Acronym / sponsor ID
- sono& mammo in breast cancer
- Conditions
- Breast Cancer
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 122 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 20 Jan 2026 (estimated)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Jan 2028 (estimated)
- First posted
- 21 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (1 listed)
- -The patients having BI-RADS IV, V, VI proven breast cancer.
Key exclusion criteria (1 listed)
- -Patients with post-neoadjuvant therapy and a prior history of breast cancer in the same breast with recurrence.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Diagnostic test: Ultrasound and MammogramPatients 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. | Other | – |
Primary outcome
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)
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.
1 secondary outcome
-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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2026.
- Background: PubMed 33628504Shaikh 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 21 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mai Abdelbaset Ahmed (+201094657457, Mai.17289680@med.aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07354490, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jan 2026.