Breast cancer
Conditions
Interventions
Gold Standard:Oncotype DX (ODX
Genomic Health, Redwood City, CA) breast cancer recurrence risk
Index test:An intelligent prediction system for breast cancer ODX risk level developed by our research group based on clinical big data and using artificial intelligence.
Sponsors
National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Eligibility
Sex/Gender
Female
Age
26 Years to 78 Years
Inclusion criteria
Inclusion criteria: 1. Invasive breast cancer was clearly confirmed by puncture pathology or biopsy pathology at the Breast Surgery Department of Cancer Hospital, Chinese Academy of Medical Sciences; 2. Surgical treatment (simple resection + sentinel lymph node biopsy or breast-conserving surgery + sentinel lymph node biopsy) at the Breast Surgery Department of Cancer Hospital, Chinese Academy of Medical Sciences; 3. Negative sentinel lymph node biopsy (no metastatic breast cancer cells seen); 4. Estrogen receptor (ER) positive; 5. Her2 negative; 6. Tumor AJCC pathological stage T0~2N0M0.
Exclusion criteria
Exclusion criteria: 1. Received neoadjuvant chemotherapy or endocrine therapy before operation; 2. The follow-up information is incomplete; 3. Positive lymph nodes; 4. The maximum diameter of the tumor is >5cm; 5. There is distant metastasis; 6. Carcinoma in situ, inflammatory breast cancer, phyllodes tumor and other breast tumors except invasive breast cancer; 7. Patients with severe cardiovascular disease, respiratory system disease, malnutrition, autoimmune disease, diabetes, liver disease, kidney disease, history of deep vein thrombosis, coagulation mechanism disorder, etc. who cannot tolerate surgery; 8. Life expectancy at the time of surgery < 12 months; 9. The patient or relatives refuse to participate in the clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ODX breast cancer recurrence risk;sensitivity;specificity;positive predictive value;negative predictive value; | — |
Countries
China
Contacts
Public ContactXiangyi Kong
This study was a single-arm study without controls.
Outcome results
None listed