Monitoring of Immune and Microbial Reconstitution in Hematopoietic Cell Transplantation (HCT) and Novel Immunotherapies
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 210
- 试验地点
- 1
- 主要终点
- Immune Function after HCT
研究概览
简要总结
This protocol serves as a mechanism to collect, store, and distribute bodily fluid and tissue samples obtained from Hematopoietic Cell Transplant (HCT) or novel immunotherapy patients and their donors at the Masonic Cancer Center in order to conduct correlative studies of the immune system, microbiota, and their interactions. Fluid (including but not limited to, blood, urine, saliva, cerebrospinal fluid, bronchoalveolar lavage fluid) sample log-in, processing, relabeling, and storage is performed by the Masonic Cancer Center (MCC) Translational Therapy Lab (TTL).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients planning to undergo HCT or other cellular therapy/immunotherapy
- •Allogeneic related donors
- •Aged 0-80
- •Willing and able to sign voluntary written consent
排除标准
- •Patients whose medical record indicates that they have opted out of research
结局指标
主要结局
Immune Function after HCT
时间窗: 7 Years
Incidence of CMV reactivation
Immune Function after Cell Therapy/Immunotherapy
时间窗: 7 Years
Incidence of cytokine release syndrome (CRS)
Correlate microbiota changes and their interactions with the host with outcomes of HCT
时间窗: 7 Years
Correlate microbiota changes and their interactions with the host with outcomes of HCT
Correlate Immune Parameters
时间窗: 7 Years
Correlate the lymphocyte phenotypes, specifically natural killer cell subsets and lymphocyte response to viral antigen.
次要结局
未报告次要终点