Discovering Outcomes in Clonal Hematopoiesis: The Clonal Hematopoiesis and Inflammation in VasculaturE (CHIVE) Registry and Biorepository
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 800
- 试验地点
- 1
- 主要终点
- CHIVE Registry
研究概览
简要总结
This study will investigate the association between clonal hematopoiesis and other conditions. Clonal hematopoiesis (CH) refers to the mutations in a person's stem cells which commonly affect people as they get older. These mutations have notably been linked to increased risk of certain cancers as well as increased risk of heart disease.
详细描述
Objectives:
- To develop the CHIVE Registry with CH patients or patients with elevated risk for CH in order to better characterize associated clinical outcomes and co-morbidities in these populations
- To improve understanding of cardiovascular phenotypes and risk of patients with known Clonal Hematopoiesis of indeterminate potential (CHIP) or Clonal Cytopenias of undetermined significance (CCUS)
- To investigate prognostic significance of CH mutations for the development hematologic malignancies
- To generate a CHIVE Biorepository to acquire patient samples to study the natural history of CH, and to make available to CH investigators.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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
- 否
入选标准
- •Patient greater than or equal to 18 years old at time of consent
- •Able to provide informed consent
- •Idiopathic cytopenia (ICUS) or idiopathic cytoses (elevated blood counts without disease or explanation); clonal cytopenia of undetermined significance (CCUS), clonal hematopoiesis of indeterminate potential (CHIP) or individuals at higher risk for clonal hematopoiesis (ex. patients with known diagnosis of solid tumors or cardiovascular disease)
排除标准
- •Unable to provide consent
- •Diagnosis of active hematologic malignancy. For example, a diagnosis of CMML, AML, MDS, MPN; History of hematologic malignancy is NOT exclusionary if in complete remission (e.g. previous myeloma or lymphoma)
结局指标
主要结局
CHIVE Registry
时间窗: Up to approximately 120 months
Aggregate data will be utilized to better understand the association between clonal hematopoiesis and other conditions
CHIVE Biorepository
时间窗: Up to approximately 120 months
Number of biological samples collected and stored (Blood, saliva, bone marrow) for future studies.
次要结局
未报告次要终点
研究者
Alexander Bick
Assistant Professor Medicine, Division of Genetic Medicine
Vanderbilt-Ingram Cancer Center