Validity of Brain Metastasis Risk Predictive Model in Hormone Positive Breast Cancer Patients

NCT06729099 | Not Yet Recruiting

• 1 other identifier: Predictive model
• Study Type: observational
• Target: 128
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study aims to validate a prediction model of brain metastasis risk for females with HR+ breast cancer by using variables collected at diagnosis.

Conditions

Breast Cancer, Estrogen Receptor-Positive

Keywords

breast cancer; Hormonal receptor positive; brain metastasis risk; Prediction model

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Medical records of women with HR+ breast cancer in clinical oncology department in Assiut University Hospital, Assiut, Egypt.

You may qualify if:

• Confirmed diagnosis of HR-positive primary invasive breast cancer.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assiut University: lead

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical oncology specialist

Study Record Dates

• First Submitted: December 8, 2024
• First Posted: December 11, 2024
• Study Start: January 1, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): June 1, 2027
• Last Updated: December 11, 2024

Record last verified: 2024-12