Prospective Cohort of Patients With Systemic Sclerosis at Brest University Hospital With Biobanking

Condition(s) studied

Investigational drug(s) / intervention(s)

Blood samples: 80 ml of blood samples collected at inclusion and at 18 months

Stool samples: A stool sample for collection of digestive microbiota at inclusion

Skin swab samples: A skin swab sample for collection of skin microbiota at inclusion and at 18 months

Questionnaires on quality of life, pain and disability: At inclusion and each year for 5 years

Skin biopsies: At inclusion and 18 months

Study summary

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.

Eligibility

Primary outcome measure(s)

• Age — 5 years
  To assess whether age correlates with disease profile and progression
• Sex — 5 years
  To assess whether sex correlates with disease profile and progression
• Weight — 5 years
  To assess whether weight correlates with disease profile and progression
• Medical history — 5 years
  To assess whether medical history predicts the pattern and course of the disease
• Family history — 5 years
  To assess whether family history predicts the pattern and course of the disease
• Rodnan score — 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)
• active digital ulcers — 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.
• dyspnea — 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)
• Free Carbon Monoxide Diffusion (DLCO) — 5 years
  Free Carbon Monoxide Diffusion (DLCO) in percentage.
• 6-minute walk test — 5 years
  Distance (in meters) covered in the 6-minute walk test.
• systemic pulmonary arterial pressures — 5 years
  Measured on cardiac ultrasound.

Trial sites (1)

More University Hospital, Brest trials in France

Other trials for the same condition