Biomarkers for Post-Transplant Lymphoproliferative Disorders in Children (CTOTC-06)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 944
- 试验地点
- 7
- 主要终点
- Incidence of Epstein-Barr Virus (EBV) Positive Post-Transplant Lymphoproliferative Disorders (PTLD)
研究概览
简要总结
Solid organ transplantation is an important therapeutic option for children with a variety of end stage diseases. However, the same immunosuppressive medications that are required to prevent the child's immune system from attacking and rejecting the transplanted organ can predispose these individuals to developing a very serious cancer that is linked to Epstein-Barr virus (EBV).
详细描述
EBV-associated post-transplant lymphoproliferative disease (PTLD) is the most common malignancy in children after transplant. Diagnosis and effective treatment of the EBV-associated cancer is hampered by our inability to determine which children are at risk of developing these cancers and to detect the cancer at an early stage. In this study, we plan to test new "biomarkers" in the blood of children that will tell us very early on if the child is at risk of developing the EBV-associated cancer or if the cancer is present. These studies provide new opportunities for detection, diagnosis, and treatment of children with EBV-associated, post-transplant cancer.
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
- — 至 21 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject and/or parent or legal guardian must be able to understand and provide informed consent/assent;
- •Candidate for or recipient of: heart, liver, heart with liver, small intestine, liver with small intestine, or kidney; and
- •Subject enrolled within 3 years of transplant.
排除标准
- •Previous diagnosis of PTLD;
- •Transplant recipients of lung alone, or in combination with an eligible organ type;
- •Pancreas transplantation with the exception of 'en bloc' transplant in combined liver and small intestine multivisceral transplantation;
- •Any combination other than listed in inclusion criteria;
- •History of any previous solid organ, stem cell, or bone marrow transplantation;
- •Inability or unwillingness of the legal guardian and/or the subject to comply with the study protocol.
研究组 & 干预措施
Subjects Enrolled Pre-Transplant
Subjects (N=approximately 357) Enrolled Pre-Transplant
- Subjects with evidence of EBV infection prior to transplant
- Subjects without evidence of EBV infection prior to transplant, who are at risk of developing EBV infection after transplant
干预措施: Immunosuppressive Drugs (Drug)
Subjects Enrolled Pre-Transplant
Subjects (N=approximately 357) Enrolled Pre-Transplant
- Subjects with evidence of EBV infection prior to transplant
- Subjects without evidence of EBV infection prior to transplant, who are at risk of developing EBV infection after transplant
干预措施: transplant (Procedure)
Subjects Enrolled Post-Transplant
Subjects (N=approximately 588) Enrolled 3 Yrs Post-Transplant
- Subjects with evidence of EBV infection prior to transplant
- Subjects without evidence of EBV infection prior to transplant, who are at risk of developing EBV infection after transplant
干预措施: transplant (Procedure)
Subjects Enrolled Post-Transplant
Subjects (N=approximately 588) Enrolled 3 Yrs Post-Transplant
- Subjects with evidence of EBV infection prior to transplant
- Subjects without evidence of EBV infection prior to transplant, who are at risk of developing EBV infection after transplant
干预措施: Immunosuppressive Drugs (Drug)
结局指标
主要结局
Incidence of Epstein-Barr Virus (EBV) Positive Post-Transplant Lymphoproliferative Disorders (PTLD)
时间窗: Receipt of transplanted organ(s) to confirmation of EBV-positive PTLD, up to year 4 post - enrollment
The development of EBV positive PTLD during the study period as assessed by the local site pathologist, with confirmation of the PTLD diagnosis by the Study Clinicopathological Review Board (SCPRB)
Specified Gain-of-Function Mutations in EBV Latent Membrane Protein 1 (LMP-1)
时间窗: Receipt of transplanted organ(s) to confirmation of mutations in EBV LMP1 , up to year 4 post - enrollment
Specified gain-of-function mutations in EBV LMP-1 (e.g., corresponding to EBV LMP-1 variants G212S or S366T) detected by polymerase chain reaction (PCR) method
Pathogenic Changes in B Cell Clonotype Development
时间窗: Receipt of transplanted organ(s) to confirmation of changes in B cell clonotype development, up to year 4 post - enrollment
Pathogenic changes in B cell clonotype development as assessed using high throughput sequencing (HTS)
次要结局
未报告次要终点