Prognostic Value of Vitamin D Levels in Egyptian Females With Breast Cancer
试验速览
- 阶段
- 不适用
- 入组人数
- 222
- 试验地点
- 1
- 主要终点
- Correlation of vitamin D levels with prognostic features
研究概览
简要总结
In our study; we aim to analyze the correlation between pre-treatment serum vitamin D (VD) levels and breast cancer prognostic features in newly diagnosed breast cancer patients presenting to our department.
详细描述
Breast cancer is the most common cancer diagnosed in females in more and less developed regions, with more cases occurring in less developed (883,000 cases) than more developed regions (794,000). In Egypt, breast cancer is the commonest cancer in females representing about (38.8%) of cancers in females.
Decades of epidemiologic research have led to the identification of a number of lifestyle and environmental breast cancer risk factors, including menstrual and/or reproductive history, use of hormones, anthropometry, and alcohol consumption, each typically explaining a modest proportion of the variation in disease risk.
Vitamin D exists as vitamin D2 (Calciferol, the storage form) and D3 (Cholecalciferol, the active form), which are metabolized to 25-hydroxyvitamin D [25(OH)D], the major circulating vitamin D metabolite; Besides, its physiological functions, vitamin D levels have also been studied as a risk factor for several hormonal cancers including breast cancer (BC). Vitamin D is not technically a vitamin, ie, it is not an essential dietary factor; rather, it is a pro-hormone produced photo-chemically in the skin from 7-dehydrocholesterol. The molecular structure of vitamin D is closely allied to that of classic steroid hormones (eg, estradiol, cortisol, and aldosterone) in that they have the same root ring structure. Technically, vitamin D is a secosteroid.
The vitamin D receptor (VDR) is a member of the nuclear receptor superfamily and plays a central role in the biological actions of vitamin D. The vitamin D receptor regulates the expression of numerous genes involved in calcium/phosphate homeostasis, cellular proliferation and differentiation, and immune response, largely in a ligand-dependent manner. To understand the global function of the vitamin D system in physio-pathological processes, great effort has been devoted to the detection of the vitamin D receptor in various tissues and cells, many of which have been identified as vitamin D targets.
According to a 2010 analysis, the vitamin D receptor significantly affects 229 human genes. Many of these genes have long been associated with autoimmune diseases and cancers. Greater than 36 types of tissue have been identified as having a Vitamin D Receptor including the breast .
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female patients
- •Newly diagnosed breast cancer patients.
- •Histologically confirmed invasive breast carcinoma (IBC)
- •Non- metastatic.
- •Treatment naïve patients.
- •Age: ≥18 and older
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or
- •Patients must have normal organ function as regards LFTs and RFTs
排除标准
- •Male patients
- •Metastatic patients
- •Previous history of breast cancer diagnosis or treatment
- •Kidney impairment or renal stones
- •History of parathyroidectomy
- •Hypercalcemia, defined as serum level >11 mg/dl.
- •Abnormal laboratory data for: AST (SGOT), ALT (SGPT), Serum Bilirubin, Alkaline phosphatase, Creatinine and/or Creatinine clearance, and Albumin.
- •Female patients who are pregnant or breast feeding.
- •Patients already on treatment or previously treated for vitamin D defeciency
结局指标
主要结局
Correlation of vitamin D levels with prognostic features
时间窗: 2 years
Analysis of the correlation between; pre-treatment serum vitamin D levels, and breast cancer prognostic features.
次要结局
- Correlation of vitamin d levels with treatment outcomes(5 years)
研究者
Dina Barakat Saber
Principal investigator
Assiut University