Evaluating the Clinical Utility of the T-SPOT.CMV Assay for the Prediction of CMV Reactivation Among Pediatric Patients Undergoing Hematopoietic Cell Transplant
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 11
- 试验地点
- 1
- 主要终点
- Percentage of the first 30 participants with at least one evaluable sample
研究概览
简要总结
The ability to distinguish allogeneic hematopoietic cell transplantation (allo-HCT) recipients at risk for cytomegalovirus (CMV) reactivation from those who are not is central for optimal CMV management strategies. Measuring this cell mediated immunity has been proposed as a potent tool to predict those patients at highest risk of CMV reactivation and disease. This study will evaluate the ability of the T-SPOT.CMV test to predict Cytomegalovirus (CMV) reactivation in allogeneic hematopoietic cell transplantation (allo-HCT) pediatric recipients.
Primary Objectives:
To evaluate feasibility of T-SPOT.CMV spot count test in allo-HCT pediatric recipients.
To evaluate association of T-SPOT.CMV spot count in the first sample collected after patient has engrafted with subsequent CMV reactivation in allo-HCT pediatric recipients.
Secondary Objectives:
To evaluate the correlation between T-SPOT.CMV spot count in donors with subsequent recipient CMV spot count.
To explore the relationship between recipient T-SPOT.CMV spot counts and subsequent CMV infection related morbidity and treatment outcomes among pediatric all-HCT recipients.
详细描述
T-SPOT response will be measured using the results from the T-SPOT.CMV blood test in both HCT recipients and HCT donors.
A blood sample for the T-SPOT.CMV blood test will be collected from the HCT donor prior to transplant.
Blood specimens will be collected for the T-SPOT.CMV blood test from HCT recipients over the course of 6 months, starting weekly at Day +1, biweekly starting at Day +45, and monthly starting at day +120.
HCT recipient participant demographic and clinical characteristics will be collected at enrollment. Additional clinical information will be abstracted from the HCT recipient participants medical record during the study follow-up period. This will include information related to transplant history and outcome, infections, antimicrobial exposure, chemotherapy, and laboratory values related to infectious diseases and immunosuppression.
The feasibility of the T-SPOT.CMV spot count test will be evaluated once the first 30 participants enrolled on study reach day +90. If 75% of patients have at least 1 evaluable samples after engraftment (> 75,000 per microtiter wells), we will proceed with enrollment. If more >25% of patients have all their samples deemed not evaluable due to insufficient mononuclear cell count (<75,000 per microtiter wells) the study will be stopped and concluded as not feasible.
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
- 是
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Percentage of the first 30 participants with at least one evaluable sample
时间窗: Day +90 after transplant
Percentage of the first 30 participants enrolled on study reach day +90 with at least one evaluable sample will be reported.
Odds ratio of subsequent reactivation
时间窗: Up to 180 days after enrollment.
We define the primary endpoint to the T-SPOT CMV count in the first sample collected after patient has engrafted, which is the time point when one establishes his/her post-transplant immunity. If the count in this sample is less than or equal to 100, the participant will be noted as "low response", while an individual with a spot count greater than 100 will be noted as "high response". Odds ratio of having subsequent CMV reactivation between "low response" and "high response" groups will be estimated.
次要结局
- Odds ratio of treatment outcomes(Up to 180 days after enrollment.)
- Hazard ratio of morbidity(Up to 180 days after enrollment.)
- Correlation coefficient of T-SPOT.CMV spot count in donors with subsequent recipient CMV spot count(Up to 180 days after enrollment.)
- Odds ratio of morbidity(Up to 180 days after enrollment.)
- Hazard ratio of treatment outcomes(Up to 180 days after enrollment.)