Validity of Brain Metastasis Risk Predictive Model in Hormone Positive Breast Cancer Patients
Study Overview
Status
Conditions
Detailed Description
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-Díaz 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.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Moheb I Moheb Ibrahim Melek, MSc in clinical oncology
- Phone Number: +201092655523
- Email: mohebmelek@med.aun.edu.eg
Study Contact Backup
- Name: Doaa Ali Gamal, MD in clinical oncology
- Phone Number: +201118118806
- Email: doaagamaal@aun.edu.eg
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Confirmed diagnosis of HR-positive primary invasive breast cancer.
Exclusion Criteria:
- Patients if they were diagnosed with brain metastases at the time of initial breast cancer diagnosis or within the subsequent three months.
- Bilateral breast cancer.
- Synchronic cancer (i.e., lung cancer, melanoma).
- Paitents presenting neurologic symptoms without follow-up or lacking a contrast-enhanced magnetic resonance image (cMRI).
- Incomplete clinicopathological information at the time of diagnosis.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Validity of prediction model of brain metastases risk for females with HR+ breast cancer
Time Frame: 2 years
|
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
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Predictive model
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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