Immunologic Profile of Patients With Newly Diagnosed Medulloblastoma at Initial Diagnosis and During Standard Radiation and Chemotherapy
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 21
- 主要终点
- Effect of treatment on lymphocytes and T-reg cells
研究概览
简要总结
RATIONALE: Studying samples of blood in the laboratory from patients receiving radiation therapy and chemotherapy may help doctors learn more about the effects of this treatment on cells. It may also help doctors understand how well patients respond to treatment.
PURPOSE: This research study is studying biomarkers in blood samples from young patients with newly diagnosed brain tumors undergoing standard radiation therapy and chemotherapy.
详细描述
OBJECTIVES:
Primary
- Evaluate the fraction of peripherally circulating T-regulatory cells (T_regs) in pediatric patients with newly diagnosed medulloblastoma and compare it to the levels found in a control group of patients undergoing craniectomy for Chiari malformation.
- Evaluate the longitudinal effects of standard radiotherapy and chemotherapy regimens on the overall population of lymphocytes as well as the fraction of T_reg cells in patients with medulloblastoma.
Secondary
- Determine the baseline fraction of T_reg cells in those with non-medulloblastoma posterior fossa tumors compared to levels found in patients undergoing decompression for Chiari malformation.
研究设计
- 研究类型
- Interventional
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 4 Years 至 21 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Meets 1 of the following criteria:
- •Histologically confirmed posterior fossa tumor
- •Newly diagnosed disease
- •Medulloblastoma OR non-medulloblastoma (pilocytic astrocytoma, ependymoma, atypical rhabdoid tumor, or others)
- •Scheduled to undergo craniotomy and tumor resection
- •Chiari malformation
- •Requires craniectomy for decompression
- •No secondary decompression
- •PATIENT CHARACTERISTICS:
- •No unexplained febrile illness
- •No active infection
- •No autoimmune disorders such as inflammatory bowel disease, juvenile rheumatoid arthritis, or systemic lupus erythematosus
- •No other immunosuppressive disorders (e.g., HIV infection)
- •PRIOR CONCURRENT THERAPY:
- •See Disease Characteristics
排除标准
- 未提供
结局指标
主要结局
Effect of treatment on lymphocytes and T-reg cells
Longitudinal side effects of standard radiotherapy and chemotherapy regimens on the overall population of lymphocytes as well as the fraction of circulating T-reg cells
Peripherally circulating T-regulatory (T-reg) cells in patients with medulloblastoma or Chiari malformation
次要结局
- Baseline fraction of circulating T-reg cells