Prognostic Value of Vitamin D Levels in Egyptian Females With Breast Cancer

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

222 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-09-01

Study Completion Date

2021-09-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Influence of Preoperative Vitamin D Level on Postoperative Pain in Breast Cancer Surgery Patients

NCT06551688

Cancer Breast Hypovitaminosis D

COMPLETED

Vitamin D and Calcium Supplementation in Breast Cancer

NCT05523609

Breast Cancer

RECRUITING PHASE2/PHASE3

Vitamin D Can Increase Pathological Response of the Breast Cancer Patients Treated With Neoadjuvant Therapy

NCT03986268

Vitamin D Deficiency Chemotherapy Effect Pathology

COMPLETED NA

Study of Vitamin D Supplementation Tailored to Vitamin D Deficiency in Breast Cancer Patients

NCT01480869

Breast Cancer

COMPLETED PHASE3

Vitamin D Supplementation in Breast Cancer Patients

NCT06596122

Peripheral Neuropathic Pain

NOT_YET_RECRUITING PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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 .

In a study by. plasma vitamin D levels were correlated with deoxyribonucleic acid (DNA) repair capacity levels in women with breast cancer.

In another study there was an association between vitamin D insufficiency or deficiency and tumors with worse prognostic features. Low vitamin D levels were shown to be a risk factor for estrogen receptor (ER) negative tumors, with positive axilla and a higher rate of cell proliferation in Brazilian postmenopausal women.

A study that evaluated serum vitamin D levels in female patients with recently identified benign or malignant lesions of the breast and its associations with tumor histology. Vitamin D was associated with tumor aggressiveness.

However, the effect of vitamin D deficiency on breast cancer prognosis and its role as a non-invasive bio-marker of breast cancer outcomes warrants further investigation.

Newly diagnosed non-metastatic breast cancer patients presenting to clinical oncology department, Assiut university Hospitals will be assessed for pre-treatment serum vitamin D levels (classified as sufficiency (30-100 ng/mL), insufficiency (20- \<30 ng/mL) and deficiency (\<20 ng/mL) through a blood sample obtained from the patient before receiving any type of treatments for their cancer and analyzed using enzyme-linked immunosorbent assay (ELISA) kit for vitamin D serum levels, patients characteristics (age, menopausal status, body mass index (BMI as weight in kilograms divided by squared height in meters (kg/m2), data on breast cancer (histopathological type, grade, tumor stage, lymph node status), hormone status (estrogen receptor (ER), progesterone receptor(PR)), human epidermal growth factor receptor type 2 (HER2) and epithelial proliferative activity described in percentage (Ki-67) will be obtained from patient file records . Time to tumor relapse whether locally or distant metastases and overall survival will be recorded. Correlation between these data and the pre-treatment vitamin D levels will be done.

* Definition of menopause: the permanent cessation of menses for 12 consecutive months in the absence of chemotherapy, tamoxifen, toremifine, or ovarian suppression and follicle-stimulating hormone (FSH) and estradiol levels in the postmenopausal range.
* Tumor grade defined according to the Nottingham (also called Elston-Ellis) modification of the Scarff-Bloom-Richardson grading system Grade 1 tumor (well-differentiated). Grade 2 tumor (moderately differentiated). Grade 3 tumor (poorly differentiated).
* Tumor stage will be classified according to American Joint Committee on Cancer (AJCC) staging manual eighth edition (2017).
* Definition of HER-2 positivity according to American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) guideline recommendations for human epidermal growth factor receptor 2 (HER2) testing in breast cancer: Testing criteria define HER2-positive status when (on observing within an area of tumor that amounts to \>10% of contiguous and homogeneous tumor cells) there is evidence of protein overexpression (IHC) or gene amplification (HER2 copy number or HER2/CEP17 ratio by ISH based on counting at least 20 cells within the area). If results are equivocal (revised criteria), reflex testing should be performed using an alternative assay (IHC or ISH).

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Vitamin D Deficiency

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_ONLY

Study Time Perspective

CROSS_SECTIONAL

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Single arm

pre-treatment serum vitamin d level measured by ELISA kit in patients confirmed for diagnosis with invasive breast cancer and before receiving any treatment for breast cancer

serum vitamin d level measured by ELISA kit

Intervention Type DIAGNOSTIC_TEST

serum vitamin d level will be measured by a blood sample from newly diagnosed breast cancer patients just after diagnosis (either by surgery specimen or FNA or excisional biopsy specimen) and before receiving any type of treatment for breast cancer

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

serum vitamin d level measured by ELISA kit

serum vitamin d level will be measured by a blood sample from newly diagnosed breast cancer patients just after diagnosis (either by surgery specimen or FNA or excisional biopsy specimen) and before receiving any type of treatment for breast cancer

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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 2.
* Patients must have normal organ function as regards LFTs and RFTs

Exclusion Criteria

* 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

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No