Observational Study for Clinical Implications of HMGB1 (High-mobility Group Protein B1) in Patients Treated With Chemotherapy or Hematopoietic Stem Cell Transplantation
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- comparison of serum HMGB1 level before and after diagnosed acute GVHD
研究概览
简要总结
Acute Graft-versus-host disease(aGVDH) after allogeneic hematopoietic stem cell transplantation is one of the meaningful issues in aspect of patient's recovery and survival. in recent years, the understanding of the pathology of GVHD is much important to prevent or treat aGVHD. additionally, (oral) mucositis is one of the problems in patients with high dose chemotherapy, and mucositis by high-dose chemotherapy is related to HMGB-1 as proinflamtory cytokines. HMGB1 is a nuclear protein acts as a transcription factor, but, if it was released to the outside of cells by damaged cell or necrotic tissues, it works as cytokines for promoter of inflammation and cancers. at this point, there are no reported articles about correlation of HMGB1 and aGVHD in human. recently, we have seen excessive secretion of serum HMGB1 in mouse model, then base on this results, we will check correlation of HMGB1 and aGVHD/ oral mucositis in human.
详细描述
-
materials 1) inclusion criteria
-
over 18-year-old
-
patients with myeloablative conditioning regimen
-
autologous transplant
-
patients with confirmation of acute GVHD as over grade II
-
patients with salvage chemotherapy
- exclusion criteria
- old age ( over 60-year-old)
- patients with reduced intensity stem cell transplantation
- method 1) check the serum level of HMGB1, TNF-a, IL-1b, IL-6, Th1, Th2, Th17, FoxP3 on 7-day before transplant day(D-7), transplant day(D0), 7-day after transplant(D+7), D+14, D+21. 2) check the immunohistochemistry level of tissue in diagnosed aGVHD ( performed sigmoidoscopy and random biopsy of gut is routine process in our center) 3) check the oral mucositis grades (using WHO grading system, NCI -CTC ver.3 scoring system)
- analysis 1) student t-test , chi-square test 2) survival analysis
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •over 18-year-old
- •patients with myeloablative conditioning regimen
- •autologous transplant
- •patients with confirmation of acute GVHD as over grade II
- •patients with salvage chemotherapy
排除标准
- •very old age ( over 75-year-old)
- •patients with reduced intensity stem cell transplantation
研究组 & 干预措施
high dose chemotherapy
group of using myeloablation regimen, autologous stell cell transplantation
干预措施: salvage chemotherapy, total body irradiation (Drug)
control group
normal population with health screening
干预措施: salvage chemotherapy, total body irradiation (Drug)
结局指标
主要结局
comparison of serum HMGB1 level before and after diagnosed acute GVHD
时间窗: 6 months
day 7 before stem cell transplantation(SCT), day 0, day 7, 14 after SCT, and date of diagnosed acute GVHD in all patients.
次要结局
- serum level of immunosuppressive drugs in patients with acute GVHD(3 months)
研究者
JEON YOUNG-WOO
medical doctor, fellowship
Seoul St. Mary's Hospital