Interaction of Vitamin D Receptor gene polymorphism with HLA alleles and itscorrelation with immune modulation affecting graft outcomes and survival in HLAmatched sibling allogeneic stem cell transplantation
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- Association of Next generation sequencing of Vitamin D receptor (VDR) gene polymorphisms in patients and donors with acute graft versus host disease.
研究概览
简要总结
The action of vitamin D3 is mediated by vitamin D receptor (VDR). The VDR is expressed on both normal and cancerous blood cells.. Around 200 variations have been identified in the VDR gene. These variations affect the protein present in the human. Bone marrow transplantation (BMT) is used to treat patients with life threatening blood cancers. In transplantation group of proteins called HLA (human leukocyte antigen) located on the surface of white blood cells and other cells in the body must be shared between a patient and donor. The more the sharing the better is the transplant outcome. The study conducted at our centre suggests that low Vit.D levels post supplementation affects transplant outcomes. Since vitamin D3 binds to vitamin D receptor (VDR) we plan to study the VDR genetic forms along with HLA genes to understand their role in graft outcome post BMT.
A total of 200 patients/donors undergoing HLA matched sibling HSCT will be included in this study. Serum vitamin D3 levels is done by ELISA as a part of pre HSCT work up in all patients. Patients who have undergone (retrospective) as well as those who will be taken for HLA matched sibling HSCT (prospective) will be included for VDR and HLA genotyping. This will include patients/donors (n=100) who underwent HSCT between December 2008 to May 2020 in the retrospective arm. Patients/donors who will undergo HSCT from the time of study approval (n=100) onwards will be included in prospective arm. Representative patients/donors from the prospective arm (n=50) will be investigated for VDR expression analysis, lymphocyte subsets, cytokine levels and expression in peripheral blood.
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
- All
入选标准
- •The patients who underwent HSCT with allogeneic matched sibling donor from December, 2008 to May, 2019 will be included in retrospective arm.
- •Patients, who will undergo HSCT from June, 2019 onwards will be included in prospective arm.
排除标准
- •Unrelated, Haplomatched or mismatched patient donor pairs will not be enrolled for the study.
结局指标
主要结局
Association of Next generation sequencing of Vitamin D receptor (VDR) gene polymorphisms in patients and donors with acute graft versus host disease.
时间窗: From date of transplant to day 100 post transplant.
次要结局
- Association of Next generation sequencing of Vitamin D receptor (VDR) gene polymorphisms in patients and donors with transplant related mortality.(1 year post transplant)
- Correlation of VDR polymorphisms with vitamin (Vit.) D namely serum 25-hydoxyvitamin D3 and 1,25-dihydroxyvitamin D3 levels pre transplantation and the effect of VDR polymorphisms on the normalization of Vit D levels post supplementation(Pretransplant and 4 months from Vit. D supplementation.)
- Association of Next generation sequencing of Vitamin D receptor (VDR) gene polymorphisms in patients and donors with overall survival.(1 year post transplant)
- Association of Next generation sequencing of Vitamin D receptor (VDR) gene polymorphisms in patients and donors with relapse free survival.(1 year post transplant)
- Immunomodulatory effect of Vit. D on the expression of the HLA gene in the patient post HSCT and its correlation with graft versus host disease.(1 year post transplant)
- Immunomodulatory effect of Vit. D on Th1 Th2 cell subsets along with cytokines in the peripheral blood cytokines post HSCT and its correlation with graft versus host disease.(Day 100 post transplant)