MS and NMOSD in African-Americans: a Prospective Data Collection Protocol Using REDCap
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- Clinical data collection and comparison
研究概览
简要总结
This is a prospective study that aims to collect and review neuromyelitis optica spectrum disorder (NMOSD) data from African American patients with a known diagnosis of multiple sclerosis (MS). It is an investigational study, prospective in nature. No randomization of patients will be done. Information collected includes: Age, gender, age at diagnosis, MRI data (access to images), clinical presentation, findings on clinical examination, lab (blood and evoked potentials) and LP test results, eye exam findings if any and treatment, if started. Additional details may include other NEUROLOGICAL diseases which are also diagnosed (if any).
详细描述
African-Americans with MS are high risk for ambulatory difficulty given aggressive disease phenotype. Disease responsiveness to FDA-approved drugs is also marginal at best.
A positive correlation between the presence of oligoclonal bands (OCBs) and progressive course of MS has been established even when adjusted for ethnicity. It is well documented that the CSF humoral immune response, including a higher IgG index is higher in African-American MS patients. Although MRI lesions, specifically cord and infra-tentorial regions, contribute to disability, the phenotype in African-American populations is also probably linked to HLA-antigen complex. No study has ever collected data as it relates to ethnic background and MS. The University of Kentucky would be the first institution to collect such data.
This is a prospective study that will collect data from patients with the known diagnosis of MS who were later classified as NMOSD from the University of Kentucky's Multiple Sclerosis Clinic. Researchers will use REDCap to store data.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •between the ages of 18 and 80
- •are African-American
- •have a diagnosis of MS and later diagnosis of NMOSD
- •have been seen at the University of Kentucky's Kentucky Neuroscience Institute
排除标准
- 未提供
结局指标
主要结局
Clinical data collection and comparison
时间窗: Through study completion, average duration of four years
Collect patient age, sex, date of birth, and date of diagnosis to examine trends among this population.
次要结局
- Diagnostic tests collection and comparison(Through study completion, average duration of four years)
- MRI analysis(Through study completion, average duration of four years)
研究者
Jagannadha R Avasarala
Professor of Neurology
University of Kentucky