Vitamin D receptor (VDR), a prognostic biomarker in triple negative breast cancer patient: Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Primary outcomes:
研究概览
简要总结
Triple-negative breast cancer (TNBC) is an aggressive subtype of breast cancer, accounting for 10–15% of all cases and characterized by the absence of estrogen receptor (ER), progesterone receptor (PR), and human epidermal growth factor receptor 2 (HER2). TNBC patients often have a poor prognosis due to limited treatment options. Vitamin D receptor (VDR) has been implicated in cancer prognosis, with previous studies suggesting its potential role in modulating immune responses and tumor suppression. This pilot study aims to investigate the association between VDR mRNA expression, vitamin D levels, and their prognostic significance in TNBC patients. A cross-sectional design will be used to compare 12 triple-Negative breast cancer (TPBC) and 12 triple-positive breast cancer (TPBC) patients treated at AVBRH Cancer Hospital, Wardha.
The primary hypothesis suggests that VDR pathway activation and serum vitamin D levels could influence TNBC progression and prognosis. Additionally, the study explores the potential for VDR to enhance immune response and improve overall survival. By examining VDR mRNA expression and vitamin D levels, the study seeks to assess vitamin D deficiency risk and its implications for primary cancer prevention and treatment strategies.
Blood samples from participants will be analysed for VDR mRNA expression and vitamin D levels. Statistical analysis will be performed using SPSS, and results will be reported at a 95% confidence interval. The expected outcome is that low VDR expression and vitamin D deficiency will be associated with poor prognosis in TNBC patients, suggesting that VDR may serve as a prognostic biomarker. This research could provide a foundation for individualized treatment approaches based on vitamin D and VDR status in TNBC patients.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- Female
入选标准
- •Participants willing to give their written informed consent
- •Breast cancer patients who were admitted to AVBRH Hospital in Sawangi, Wardha, and who would visit the hospital for treatment or follow-up will be the Participants of this study.
- •Newly or old diagnosed Breast cancer (triple negative-ER, PR and Her2) or (triple positive-ER, PR and Her2) who received (at least six months prior to study registration) or who are receiving treatment (chemotherapy, radiation, and surgery) will be the study participant.
- •Female gender with age 18–65 years and whose body mass index (BMI) is in between 18 to 35 kg/m2 will be enrolled
- •Participants who did not get oral vitamin D3 supplements or intramuscular injections for a minimum of four months prior to study enrollment
- •Participants who agree to avoid from using food and herbal supplements while the intervention is conducted.
排除标准
- •Past medical records pertaining to malabsorption syndrome, disorders related to calcium metabolism, gastrointestinal, renal, inflammatory, and other endocrinological conditions that could potentially impede the study; receiving weight loss medication
- •Pregnancy and lactation
- •Participants with a known seizure disorder
- •Participants with known symptomatic cardiac disease, such as arrhythmias or coronary artery diseases.
结局指标
主要结局
Primary outcomes:
时间窗: 1 year
Outcome will be measured by evaluating the low VDR mRNA expression levels compare with both the groups to define as a predictive biomarker to ascertain the prognosis of a TNBC patient
时间窗: 1 year
Secondary Outcomes:
时间窗: 1 year
Secondary Outcomes will be evaluated by analyzing vitamin D levels and may be used to define vitamin D deficiency risk and enable individualized primary cancer prevention and therapy for better prognosis of TNBC patients.
时间窗: 1 year
次要结局
- Primary outcomes:(Outcome will be measured by evaluating the low VDR mRNA expression levels compare with both the groups to define as a predictive biomarker to ascertain the prognosis of a TNBC patient)
- Recent studies provide evidence on the prognostic significance of VDR in breast cancer, and their conclusions imply that VDR expression could be employed as a predictive biomarker to ascertain the prognosis of a patient with breast cancer(2nd year)
研究者
Dr Jaishriram Rathored
Datta Meghe Institute of Higher Education and Research, Wardha