Evaluation of the Pathobiology of CALR-mutated MPN Cells
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 35
- 试验地点
- 4
- 主要终点
- Expression levels of TLR 2 and TLR 4
研究概览
简要总结
The purpose of this study is to understand why there is a greater risk of thrombosis in patients who have the JAK2 mutation as compared to those with CALR mutations.
详细描述
This biospecimen study is designed to evaluate the expression levels of TLR 2 and TLR 4 on mononuclear cells in CALR mutation positive MPN participants and compare to JAK2 V617F mutation positive MPN patients and healthy controls. Patients who have MPN with the CALR mutation positive will be approached for interest in participating in this study. A research blood collection will occur at any time during the participant's cancer trajectory after enrollment, during a standard of care blood draw. The participant's demographics, MPN subtype, CALR mutation status, history of thrombosis/other medical history, and current, concomitant medications will be collected once. Clinical data will be collected, including results from the CBC with differential, complete metabolic panel (if available), and PT/PTT/INR (if available) drawn closest to the research blood collection. This study will initially open as a single center study at AHWFBCCC.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Written (or electronic) informed consent and HIPAA authorization for release of personal health information by participant or his/her legally authorized representative (LAR).
- •Age ≥ 18 years at the time of enrollment
- •Diagnosis of myeloproliferative neoplasm (MPN) according to 2022 World Health Organization classification of MDS/MPNs
- •CALR-positive genetic mutation
排除标准
- •- Diagnosis of MPN with JAK2 V617F mutation
研究组 & 干预措施
JAK2 V617F mutation positive MPN patients
Patients with MPN disease with a JAK2 mutation
干预措施: Blood Draw (Other)
CALR-mutation positive patients
Patients with MPN disease with a CALR mutation
干预措施: Blood Draw (Other)
结局指标
主要结局
Expression levels of TLR 2 and TLR 4
时间窗: 24 months
Percentages of mononuclear cells expressing TLR 2 and TLR 4 will be calculated for each participant.
次要结局
- Plasma levels of inflammatory cytokines(24 months)
- History of thrombosis(24 months)
- Plasma levels of inflammatory cytokines following incorporation of TLR ligands(24 months)