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A Clinical Study on Integrating Digital Twin–Based Germline Genomic Etiology and Imaging for Breast Cancer Risk Assessment and Ultra-Early Diagnosis

A Clinical Study on Integrating Digital Twin–Based Germline Genomic Etiology and Imaging for Breast Cancer Risk Assessment and Ultra-Early Diagnosis

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2600116421
Enrollment
Unknown
Registered
2026-01-09
Start date
2026-01-15
Completion date
Unknown
Last updated
2026-05-04

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:Pathological diagnosis
Index test:"Three-in-One" Diagnostic Model

Sponsors

Zhujiang Hospital of Southern Medical University
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
30 Years to No maximum

Inclusion criteria

Inclusion criteria: 1.Voluntarily participate in the study and sign the informed consent form. 2.Age: The research subjects are female participants aged >=30 years old, mainly targeting the high-risk population. 3.Breast nodules: Patients with breast nodules whose imaging BI-RADS classification (including mammography, breast ultrasound, and breast magnetic resonance imaging [MRI]) is grade 4A or below. 4.No history of malignant tumors. 5.No systemic immune diseases (e.g., systemic lupus erythematosus) and no acute severe infections within the past six months.

Exclusion criteria

Exclusion criteria: 1.Failure to sign the informed consent form. 2.Age: Female patients under 30 years old. 3.Tumor history: Patients with a previous diagnosis of breast cancer or other malignant tumors. 4.Patients with acute or chronic mastitis within the past six months. 5.Patients with systemic immune diseases, or those who had severe infections within the past six months. 6.Patients with a history of bone marrow transplantation, stem cell transplantation, radiotherapy or chemotherapy. 7.Others: Patients who are unable to complete follow-up due to other medical conditions.

Design outcomes

Primary

MeasureTime frame
Activity Profiles of Signalling Pathways;Incidence of breast cancer;Breast precancerous lesion;Sensitivity ;Specificity;

Countries

China

Contacts

Public ContactMei Yang

Zhujiang Hospital of Southern Medical University

yangmei286@163.com+86 137 2542 1149

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: May 7, 2026