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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Adults with systemic sclerosis | It is a descriptive cohort of systemic sclerosis patients |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blood samples | Other | 80 ml of blood samples collected at inclusion and at 18 months |
|
| Measure | Description | Time Frame |
|---|---|---|
| Age | To assess whether age correlates with disease profile and progression | 5 years |
| Sex | To assess whether sex correlates with disease profile and progression | 5 years |
| Weight | To assess whether weight correlates with disease profile and progression | 5 years |
| Medical history | To assess whether medical history predicts the pattern and course of the disease | 5 years |
| Family history | To assess whether family history predicts the pattern and course of the disease | 5 years |
| Rodnan score | 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) | 5 years |
| active digital ulcers | 4 characteristics must be taken into account:
| 5 years |
| dyspnea |
| Measure | Description | Time Frame |
|---|---|---|
| SF-36 (Short-Form 36) | The SF-36 is an indicator of health status and quality of life. The SF-36 has eight dimensions; the scores are weighted sums of the questions in each section. This scores range from 0 - 100. Lower scores indicate more disability and higher scores less disability. The eight dimensions of this score are:
|
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Inclusion Criteria:
Exclusion Criteria:
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Major patient with systemic sclerosis defined according to the EULAR 2013 criteria
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Claire DE MOREUIL | Contact | 0033298145303 | claire.demoreuil@chu-brest.fr | |
| Bénédicte ROUVIERE | Contact | 0033298347345 | benedicte.rouviere@chu-brest.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHRU de Brest | Recruiting | Brest | 29200 | France |
All collected data that underlie results in a publication
Data will be available after the publication of result and ending fifteen years following the last visit of the last patient
Data access requests will be reviewed by the internal committee of Brest UH. Requestors will be required to sign and complete a data access agreement
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Blood samples 80 ml of blood samples collected at inclusion and at 18 months ((60 ml for Peripheral blood mononuclear cell, 6 ml for plasma, 6 ml for sero, 6 ml for DNA and 2.5 ml for RNA)
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
Skin biopsy (optional) at inclusion and at 18 months
Questionnaires on quality of life, pain and disability At inclusion and each year for 5 years
| Stool samples | Other | A stool sample for collection of digestive microbiota at inclusion |
|
| Skin swab samples | Other | A skin swab sample for collection of skin microbiota at inclusion and at 18 months |
|
| Questionnaires on quality of life, pain and disability | Other | At inclusion and each year for 5 years |
|
| Skin biopsies | Other | At inclusion and 18 months |
|
| 5 years |
| Free Carbon Monoxide Diffusion (DLCO) | Free Carbon Monoxide Diffusion (DLCO) in percentage. | 5 years |
| 6-minute walk test | Distance (in meters) covered in the 6-minute walk test. | 5 years |
| systemic pulmonary arterial pressures | Measured on cardiac ultrasound. | 5 years |
| 5 years |
| BPI : Pain scale | A quick and easy way to measure the intensity of pain and its impact on daily activities. Patients rate the maximum, minimum, average and current intensity of their pain and the influence of pain on seven aspects of functional ability. 3 scores are obtained between 0 and 10, with 10 corresponding to :
| 5 years |
| HAQ- Health Assessment Questionnaire - Disability Index | Evolution of HAQ-DI (Health Assessment Questionnaire - Disability Index) during follow-up 8 fields questionnaire (DRESSING & GROOMING, ARISING, EATING, WALKING, HYGIENE, REACH, GRIP, Other activities), scaled from 0 to 3, 3 meaning a worse outcome | 5 years |
| ID | Term |
|---|---|
| D012595 | Scleroderma, Systemic |
| ID | Term |
|---|---|
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D001800 | Blood Specimen Collection |
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |
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