A Pilot Study of 13Carbon-Based Deep Labeling of Bone Marrow Cells to Map Their Utilization of Extracellular Metabolites
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- Mayo Clinic
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Extracellular uptake of glucose and amino acids (AAs) between pre-malignant clonal plasma cells (cPCs) and polyclonal plasma cells (pPCs)
研究概览
简要总结
This study evaluates a novel laboratory method to study how certain bone marrow cells in the body take up nutrients from their environment.
详细描述
PRIMARY OBJECTIVE:
I. Evaluate differences in the amount of extracellular uptake of glucose and amino acids (AAs) between pre-malignant clonal plasma cells (cPCs) and polyclonal plasma cells (pPCs).
OUTLINE: This is an observational study. Participants are assigned to 1 of 2 groups.
GROUP I: Patients undergo blood collection and bone marrow aspiration as part of their standard care and have their medical records reviewed on study.
GROUP II: Healthy volunteers undergo blood collection and bone marrow aspiration on study.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
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
- •All Participants:
- •At least age 18 years or older
- •Able to provide informed consent
- •MGUS Cohort:
- •International Myeloma Working Group (IMWG) criteria for the diagnosis of non-IgM MGUS
排除标准
- •All Participants:
- •Unable to provide consent
- •Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) >1
- •Prior history of adverse events with conscious sedation
- •Ongoing use of immunosuppressive medications
- •All known pregnant and lactating women will be excluded
结局指标
主要结局
Extracellular uptake of glucose and amino acids (AAs) between pre-malignant clonal plasma cells (cPCs) and polyclonal plasma cells (pPCs)
时间窗: Up to 30 days
Assessed by evaluating blood and bone marrow aspirate samples for mean 13Carbon (13C) percentage enrichment of the mass isotopomers of interest of at least 6 (i.e. the difference between a mean 13C percentage enrichment of a particular mass isotopomer is 12% in the MGUS group and 6% in the healthy participant group or vice versa) using a 2-group t-test with a 2-sided significance level of 0.01.
次要结局
未报告次要终点