Clinical and Molecular Characteristics of Histiocytic Disorders
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Mayo Clinic
- 入组人数
- 500
- 试验地点
- 2
- 主要终点
- Change in PD-L1 and T-cell Bim expression
研究概览
简要总结
This study is being done to collect medical and personal histories as well as a samples of blood, other body fluid and/or tumor/disease tissue for current and future research studies on histiocytic disorders.
详细描述
PRIMARY OBJECTIVES:
I. Define molecular signature and genomic landscape of histiocytic disorders. II. Correlate genomic findings with transcriptional abnormalities. III. Identify promising prognostic alterations and potential therapeutic targets.
OUTLINE: This is an observational study.
Patients complete questionnaires and undergo blood and tissue sample collection. Patients' medical records are also reviewed.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Other
入排标准
- 年龄范围
- 1 Year 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients diagnosed with histiocytic disorders and age ≥1 year
排除标准
- •< 1 years age
结局指标
主要结局
Change in PD-L1 and T-cell Bim expression
时间窗: Baseline; post-treatment (estimated up to 2 years, potentially 4 times per year)
Blood testing will be performed for soluble PD-L1 and T-cell Bim expressions before and after radiation therapy for histiocytic disease to assess change in levels and role of immunotherapy. For any test results that are actionable, patients will be notified and the results will be available in the electronic medical record.
Identify molecular markers
时间窗: Baseline
Biopsy samples will be analyzed for the presence of molecular markers associated with histiocytic disorders. Potential markers include BRAF V600E, cyclinD1, PD-L1, p16, and p53.6. For any test results that are actionable, patients will be notified and the results will be available in the electronic medical record.
次要结局
未报告次要终点