Development of a Multi-biomarker Panel for Prognostic Stratification and Treatment Response Prediction in Acute Graft Versus Host Disease of the Gut
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Identify a set of biomarkers capable of stratifying the overall risk of developing grade 2-4 GI GVHD in adult and pediatric patients with hematological diseases undergoing allogeneic hematopoietic cell transplantation.
研究概览
简要总结
Allogeneic hematopoietic stem cell transplantation (allo-HSCT) is a life-saving treatment for many malignant hematologic diseases. Its curative potential is due to both high-dose chemotherapy and the graft-versus-host disease (GvHD) process, in which the donor's T cells recognize the recipient's tissue as foreign. However, GvHD is a potentially fatal complication that significantly affects both survival and quality of life. GvHD can be acute or chronic, and one of the main target organs involved in acute GvHD is the intestine, with a high rate of treatment failure and mortality. We expect to identify a set of biomarkers, both clinical and experimental, that will enable the stratification of patients based on prognosis and response to treatment in intestinal GvHD. The ultimate goal of the study is to integrate clinical, transplant, and biomarker data into a robust predictive algorithm. This tool will enable personalized therapeutic approaches based on early biomarkers, improving prognostic accuracy for patient outcomes and optimizing therapeutic strategies.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 12 Years 至 —(Child, Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged ≥ 12 years
- •Indication for allogeneic HSCT
- •Obtaining informed consent
排除标准
- 未提供
研究组 & 干预措施
Patients with hematological diseases treated with allogeneic hematopoietic cell transplantation
干预措施: Adult and pediatric patients with hematological diseases treated with allogeneic hematopoietic cell transplantation (Other)
结局指标
主要结局
Identify a set of biomarkers capable of stratifying the overall risk of developing grade 2-4 GI GVHD in adult and pediatric patients with hematological diseases undergoing allogeneic hematopoietic cell transplantation.
时间窗: Between the infusion of the transplant and the following 120 days
次要结局
- Identification of biomarkers for mortality risk stratification and immunological and nutritional profiling in GvHD(After the start of therapy. Nutritional aspects will be assessed upon the patient's admission to the ward and at the onset of the event (GVHD))
