Validation of Core Biopsy of Vascular Anomalies for Clinical Pathology and Genomics
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 3
- 试验地点
- 2
- 主要终点
- Adequacy of core biopsy of vascular anomalies for clinical pathology evaluation
研究概览
简要总结
The purpose of this research is to gather information on the safety and effectiveness of core biopsy of vascular anomalies for clinical pathology and clinical genomics studies.
详细描述
Vascular anomalies or vascular malformations often are treated with minimally invasive sclerotherapy, embolization or ablation based on clinical and imaging features without acquisition of tissue. Over the last two decades there have been significant advancements in the understanding of the genetic basis for various vascular anomalies/malformations, which may guide use of therapies for individualized treatment.
As such, given the emergence of novel medications for treatment of vascular anomalies/malformations based on genetic information, acquisition of tissue for pathology and genomic characterization will be increasingly important as treatment of vascular anomalies/vascular malformations moves toward individualized medicine approach.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
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
- •Patients with a clinical and imaging diagnosis of a vascular anomaly.
- •No prior treatment for the vascular anomaly.
- •Subjects undergoing clinically indicated sclerotherapy, embolization and/or ablation.
- •Male or female with age greater than or equal to 18 years.
- •Capacity and willingness to provide a written informed consent..
排除标准
- •Subjects with prior treatment for their vascular anomaly.
- •Uncorrectable coagulopathy.
- •Pregnant and/or breast-feeding subjects. A negative pregnancy test within 48 hours of the procedure.
结局指标
主要结局
Adequacy of core biopsy of vascular anomalies for clinical pathology evaluation
时间窗: 18 months
Tissue from the vascular anomaly biopsies will undergo histopathology and immunohistochemical staining to determine the adequacy of vascular anomaly core biopsy for clinical pathology characterization.
Adequacy of core biopsy of vascular anomalies for clinical genomics studies
时间窗: 18 months
DNA and RNA will be extracted from the biopsy specimens, undergo qualitative/quantitative quality control assessment and be analyzed by whole genome sequencing (DNA) and RNA sequence analysis (RNA-seq) to determine the adequacy of vascular anomaly biopsy for vascular anomaly genomics characterization.
次要结局
- Safety of vascular anomaly core biopsy(30 days)
研究者
Emily C. Bendel, M.D.
Principal Investigator
Mayo Clinic