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This study aims to validate a prediction model of brain metastasis risk for females with HR+ breast cancer by using variables collected at diagnosis.
Data collection:
Age at BC diagnosis, tumor size, axillary adenopathy, clinical stage, HER2 status, Ki67 proliferation index and the modified Scarff-Bloom-Richardson grade of differentiation.
Analysis Plan:
Continuous variables as means and standard deviation (SD) if they follow a normal distribution; if not, as medians and IQR (interquartile range). Numbers and percentages display categorical variables.
Model validation:
The association between covariates and the diagnosis of brain metastases by performing logistic regression analyses; odds ratio (OR), 95 % confidence intervals (CI), and p-value will be estimated. Variables with a p-value < 0.05 in the univariate logistic regression analysis will be further assessed in a multivariate logistic regression analysis.
For the clinical use of the model, we will use a score to each variable as that designed by Cacho-DÃaz B. et. al. then, we will categorize patients into three risk groups according to the sum of the scores. We will employe a Cox regression analysis to assess each group's risk of developing brain metastases. Adjusted hazard ratios (aHRs), 95 % CIs, and p values will be evaluated.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low-risk group | Brain metastasis risk prediction model score 0-4 points. | ||
| Medium-risk group | Brain metastasis risk prediction model score 5-10 points. | ||
| High-risk group | Brain metastasis risk prediction model score >10 points. |
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| Measure | Description | Time Frame |
|---|---|---|
| Validity of prediction model of brain metastases risk for females with HR+ breast cancer | A Cox regression analysis to assess each group's risk of developing brain metastases. Adjusted hazard ratios (aHRs), 95 % CIs, and p values will be evaluated. | 2 years |
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Inclusion Criteria:
Exclusion Criteria:
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Medical records of women with HR+ breast cancer in clinical oncology department in Assiut University Hospital, Assiut, Egypt.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Moheb I Moheb Ibrahim Melek, MSc in clinical oncology | Contact | +201092655523 | mohebmelek@med.aun.edu.eg | |
| Doaa Ali Gamal, MD in clinical oncology | Contact | +201118118806 | doaagamaal@aun.edu.eg |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| D017437 |
| Skin and Connective Tissue Diseases |