Prospective Cohort of Patients With Systemic Sclerosis at Brest University Hospital and Constitution of a Biobank
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Medical history
研究概览
简要总结
This study corresponds to a monocentric prospective cohort of adult patients with systemic sclerosis.
It will allow the constitution of an organized collection of longitudinal clinical data as well as collection of biological samples, including blood samples, as well as stool sample and skin swab for microbiota analysis.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Major patient with systemic sclerosis defined according to the EULAR 2013 criteria (see Appendix 1)
- •Patient evaluated within the framework of the reference center for rare autoimmune diseases of the CHU of Brest.
- •Patient affiliated to the social security system
- •Patient having signed a written informed consent.
排除标准
- •Patient under legal protection (guardianship, curatorship)
- •Refusal to participate
- •Patient unable to consent
- •Pregnant or breastfeeding woman
- •Hemoglobin (Hb) level < 7g/dl
结局指标
主要结局
Medical history
时间窗: 5 years
To assess whether medical history predicts the pattern and course of the disease
Weight
时间窗: 5 years
To assess whether weight correlates with disease profile and progression
Age
时间窗: 5 years
To assess whether age correlates with disease profile and progression
dyspnea
时间窗: 5 years
* stage I: absence of dyspnea for usual efforts: no discomfort is felt in everyday life, * stage II: dyspnoea for usual heavy exertion, such as brisk or hill walking or climbing stairs (≥ 2 floors), * stage III: dyspnea for low intensity efforts of everyday life, such as walking on flat ground or climbing stairs (\< 2 floors), * stage IV: permanent dyspnea at rest or for minimal effort (putting on a garment, for example)
active digital ulcers
时间窗: 5 years
4 characteristics must be taken into account: 1. the type of ulcer: mechanical/on calcinosis/ischemic 2. the recent/semi-recent/chronic character, 3. the painful character or not, 4. the total number of fingers affected on the 10 fingers.
6-minute walk test
时间窗: 5 years
Distance (in meters) covered in the 6-minute walk test.
systemic pulmonary arterial pressures
时间窗: 5 years
Measured on cardiac ultrasound.
Sex
时间窗: 5 years
To assess whether sex correlates with disease profile and progression
Family history
时间窗: 5 years
To assess whether family history predicts the pattern and course of the disease
Rodnan score
时间窗: 5 years
This score evaluates the thickness of the skin from 0 to 51. 0 meaning the absence of scleroderma (the healthiest score) and 51 completely sclerotic skin (the worst possible score)
Free Carbon Monoxide Diffusion (DLCO)
时间窗: 5 years
Free Carbon Monoxide Diffusion (DLCO) in percentage.
次要结局
- SF-36 (Short-Form 36)(5 years)
- BPI : Pain scale(5 years)
- HAQ- Health Assessment Questionnaire - Disability Index(5 years)