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Breast Cancer Molecular Subtypes and Skeletal Metastases Patterns on Bone Scintigraphy

Observational Breast Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Breast Cancer. Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Egypt
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Association of Breast Cancer Molecular Subtypes With Patterns of Skeletal Metastases on Bone Scintigraphy

Overview

The goal of this observational study is to evaluate the association between different molecular subtypes of breast cancer and their specific patterns of skeletal metastases on Technetium-99m MDP bone scintigraphy. The study will include adult male and female patients aged 18 to 80 years with histopathologically confirmed breast cancer who are referred for whole-body bone scintigraphy. The main questions it aims to answer are: * What is the frequency and pattern of skeletal metastases across different breast cancer molecular subtypes (Luminal A, Luminal B, HER2-enriched, and Triple-Negative) on bone scintigraphy? * How do nuclear medicine scintigraphic findings correlate with tumor biomarker profiles? Researchers will compare imaging patterns among the different molecular subtype groups to determine if specific biomarker profiles correlate with distinct bone metastatic behaviors.

Primary outcome measures

  • Presence of skeletal metastases on Tc-99m MDP whole-body bone scintigraphy. [Time frame: Baseline]
  • Anatomical distribution of skeletal metastases. [Time frame: Baseline]

Eligibility criteria

Inclusion criteria

  • Patients of both sexes (females and males) with a confirmed histopathological diagnosis of breast cancer, including all major histological types: Invasive Ductal Carcinoma (IDC), Invasive Lobular Carcinoma (ILC), other mixed or less common epithelial variants.
  • Patient's age ranging from 18 to 80 years.
  • Available immunohistochemical (IHC) profiles from the primary breast tumor biopsy or surgery, covering all molecular subtypes including; Luminal A: (ER-positive, PR-positive, HER2-negative, and low Ki-67 index). Luminal B: (ER-positive, PR-variable, HER2-variable "either positive or negative", and high Ki-67 index). HER2-enriched: (ER-negative, PR-negative, and HER2-positive). Triple-Negative breast cancer (TNBC): (no ER, PR or HER2 expression).
  • Patients referred for bone scintigraphy as part of initial staging, follow-up, or due to clinical suspicion of bone metastasis.

Exclusion criteria

  • Patients with other primary malignancies (to avoid confusion regarding the origin of bone metastases).
  • Patients with incomplete medical records or unavailable immunohistochemical data.
  • Pregnant female patients.
  • Patients aged under 18 years old.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Egypt · 1 center
  • Faculty of Medicine Sohag University — Sohag

Identifiers

NCT: NCT07750340 · Soh-Med-26-7-10MS

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗