Severity Factors of Dermatomyositis in the Caribbean Population - DM-ANTILLES
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- severity of dermatomyositis at diagnosis
研究概览
简要总结
Dermatomyositis is a rare chronic autoimmune and inflammatory disease that affects the skin and striated muscles. Its prognosis is linked to visceral involvement (lungs, heart, and oropharyngeal region) and to the possible presence of associated cancer. The implementation of the research will allow identification of incident cases of dermatomyositis in Guadeloupe and the characterization of the disease in the overseas population, in the absence of data in the literature.
详细描述
In the French West Indies, this condition is associated with high short- and medium-term morbidity and mortality. Diagnostic delays and patient care pathways may help explain this. However, a particularly severe phenotype of the disease in Antillean patients may also play a role, as observed in other autoimmune and inflammatory diseases we have described in overseas populations (e.g., systemic sclerosis, sarcoidosis).
Identifying factors associated with the severity of dermatomyositis at the time of diagnosis would allow for the early implementation of a tailored management strategy to improve the disease prognosis in the target population.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient with a diagnosis of dermatomyositis according to the 2003 ENMC criteria
- •Patient with parents or grandparents originating from the Caribbean arc
- •Patient aged 16 years or older
- •Patient residing in Guadeloupe
- •Patient (or legal representative) who has received information about the study and has signed the informed consent form
- •Patient affiliated with a social security scheme
排除标准
- •Patient who started treatment with intravenous immunoglobulins, corticosteroids, or immunosuppressants within the month prior to the diagnosis of dermatomyositis
- •Patient under legal protection (guardianship or trusteeship) or deprived of liberty
结局指标
主要结局
severity of dermatomyositis at diagnosis
时间窗: Assessed at baseline (diagnosis).
The primary outcome measure is the severity of dermatomyositis at diagnosis, defined by the presence of one or more of the following criteria: Muscle involvement resulting in functional disability; Associated visceral involvement, including the heart, lungs, or oropharyngeal region; Associated cancer, either previously diagnosed within the past three years or diagnosed concurrently with dermatomyositis.
次要结局
- Mortality(Assessed over 2 years from the date of dermatomyositis diagnosis)
- Relapse Occurrence(Assessed over 2 years from the date of dermatomyositis diagnosis)
- Cancer Occurrence(Assessed over 2 years from the date of dermatomyositis diagnosis)