NCT01808937招募中不适用
Immunologic and Genetic Profiles in Subsets of Morphea Patients
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 500
- 试验地点
- 2
- 主要终点
- Activity/damage measurement in morphea as scored on the Localized Scleroderma Cutaneous Assessment Tool (LoSCAT)
研究概览
简要总结
The Morphea in Adults and Children (MAC) cohort is the first registry for both children and adults with morphea (also known as localized scleroderma) in the country. The purpose of the registry is to learn more about morphea, specifically:
- How morphea behaves over time
- How frequently specific problems occur along with morphea (for example, arthritis)
- Whether morphea has an autoimmune background
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
- — 至 90 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patient must have a clinical diagnosis of morphea confirmed by the primary investigator and by histopathological examination.
- •Ages 0-90 years old
- •Children must weigh more than 20 lbs. in order to satisfy Children's Medical Center policy for the maximum amount of blood drawn in a 24 hour period.
- •Patient or legal guardian must be able to speak and read at a 6th grade reading level.
- •Both male and female patients will be eligible
- •All races and ethnic backgrounds will be included
- •Relationships to proband: All patients with morphea will be included. A patient's family history will be reviewed and if there is a family history of morphea or systemic sclerosis then we will give the study patient the investigator's contact information and ask the family member to call the study team to answer any questions and enroll them in the study if they choose to do so.
- •Ability to give informed consent: Patients must be able to give informed consent or they will give assent with parent or guardian consent as a minor to be a part of the morphea registry.
排除标准
- •- Patients who have been coded as morphea (701.0), but do not have morphea/localized scleroderma (examples: steroid atrophy, acquired keratoderma, keloids, nephrogenic fibrosing dermopathy, systemic sclerosis, lichen sclerosis)
结局指标
主要结局
Activity/damage measurement in morphea as scored on the Localized Scleroderma Cutaneous Assessment Tool (LoSCAT)
时间窗: 5 years
次要结局
- Quality of life scores measured by the Dermatology Life Quality Index (DLQI)(5 years)
研究者
Heidi Jacobe
PROFESSOR
University of Texas Southwestern Medical Center
研究点 (2)
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