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Research on Novel Technologies and Strategies for Precision Diagnosis and Treatment of Malignant Tumors: Development and Application of a Multimodal Screening and Diagnostic Model for BRCA1/2 Gene Mutations Based on Breast Cancer Imaging Pathomics

Research on Novel Technologies and Strategies for Precision Diagnosis and Treatment of Malignant Tumors: Development and Application of a Multimodal Screening and Diagnostic Model for BRCA1/2 Gene Mutations Based on Breast Cancer Imaging Pathomics

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500101007
Enrollment
Unknown
Registered
2025-04-18
Start date
2025-05-15
Completion date
Unknown
Last updated
2025-04-21

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

Conditions

Breast cancer

Interventions

Gold Standard:DNA sequencing
Index test:A Multimodal Screening and Diagnostic Model for BRCA1/2 Gene Mutations Based on Breast Cancer Imaging Pathomics.

Sponsors

Zhejiang Cancer Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1.Age >=18 years. 2.Histologically confirmed diagnosis of invasive breast cancer. 3.Completion of multigene germline mutation testing, including BRCA1/2 genes. 4.Availability of complete: personal medical history, clinicopathological data, family history of cancer. 5.Availability of pretreatment pathological slide images of primary lesions with hematoxylin and eosin (H&E) staining, obtained prior to pharmacotherapy or radiotherapy. 6.Availability of pretreatment contrast-enhanced breast MRI (magnetic resonance imaging) data.

Exclusion criteria

Exclusion criteria: 1.Failure to provide complete: personal medical history, family cancer history, clinicopathological data; 2.Breast cancer H&E-stained pathological slides meeting either of the following: obtained after neoadjuvant therapy, showing only ductal carcinoma in situ (DCIS); 3.Incomplete breast MRI imaging sequences, including but not limited to: non-contrast scans without contrast-enhanced sequences, missing key anatomical planes (e.g., axial/sagittal/coronal); 4.Incomplete BRCA1/2 gene testing: testing limited to hotspot mutations without full gene sequencing, lack of comprehensive variant analysis (e.g., large genomic rearrangements not assessed);

Design outcomes

Primary

MeasureTime frame
Accuracy;F1 score;

Countries

China

Contacts

Public ContactWenming Cao

Zhejiang Cancer Hospital

urall@163.com+86 571 88122078

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026