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| ID | Type | Description | Link |
|---|---|---|---|
| 2020-A03066-33 | Other Identifier | ID-RCB number,ANSM |
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| Name | Class |
|---|---|
| Association pour la Formation et la Recherche en Médecine Interne (AFORMI) | UNKNOWN |
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Systemic sclerosis is an autoimmune and inflammatory disease characterized primarily by fibrosis and vascular involvement. We know that the immune system is disrupted in systemic sclerosis, but there are probably other mechanisms to explain the disease, including deregulation of certain proteins such as prolactin
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with systemic sclerosis | The study will be systematically offered to any scleroderma patient seen in scheduled hospitalization |
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| Healthy subjects | Healthy subjects who will donate blood to the French Blood Establishment (EFS) and matched to scleroderma patients on age (+/- 5 years) and sex |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| blood test | Biological |
|
| Measure | Description | Time Frame |
|---|---|---|
| the prevalence of hyperprolactinemia in scleroderma patients | Rate of prolactin measured by immuno-chemiluminescence (Abbott Architect automaton). The presence of a defined hyperprolactinemia at the University Hospital of Lille: for women, prolactin level higher than 26.5 ng/mL and for men, higher than 19.4 ng/mL. | At 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| the prevalence of hyperprolactinemia between scleroderma patients and healthy subjects matched by age and sex | At 2 years | |
| the associations between prolactin levels and clinical (scleroderma phenotype, visceral involvement) and biological (inflammation, antibodies, cytokines) manifestations in systemic sclerosis |
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Inclusion Criteria:
Scleroderma patients:
Healthy subjects:
Exclusion Criteria:
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Scleroderma patients are from scheduled hospitalization Department of Internal Medicine and Clinical Immunology, CHU Lille Healthy subjects are from the French Blood Establishment (EFS) and matched to scleroderma patients on age (+/- 5 years) and sex
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| Name | Affiliation | Role |
|---|---|---|
| David Launay, MD,PhD | University Hospital, Lille | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hop Claude Huriez Chu Lille | Lille | 59037 | France |
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| ID | Term |
|---|---|
| D012595 | Scleroderma, Systemic |
| D045743 | Scleroderma, Diffuse |
| D006966 | Hyperprolactinemia |
| ID | Term |
|---|---|
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012871 | Skin Diseases |
| D006964 | Hyperpituitarism |
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| ID | Term |
|---|---|
| D006403 | Hematologic Tests |
| ID | Term |
|---|---|
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D008919 | Investigative Techniques |
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serum
|
| At 2 years |
| association between prolactin levels and biological markers of the immune system in scleroderma patients | At 2 years |
| D010900 | Pituitary Diseases |
| D007027 | Hypothalamic Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D004700 | Endocrine System Diseases |