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The GRAMI-BIO study is a prospective single-centre cohort study to recruit 150 patients followed up in the the Bordeaux University Hospital. The total duration of the GRAMI-BIO study is ten years (five years of inclusion with five years of follow-up): Consecutive inclusion of patients meeting the definition of systemic granulomatosis. The main objective of this cohort is to describe to clinical progression of systemic granulomatosis and to collect blood fraction samples (serum bank, plasma bank, urine bank, DNA bank) from subjects participating in the cohort.
Systemic granulomatosis is a group of diseases whose common feature is the anatomopathological existence of giganto-cellular granulomas composed of macrophages, epithelial cells and CD4+ T lymphocytes. The exact cause of the development of these granulomas remains unknown, although numerous studies suggest the hypothesis of environmental factors (infectious, exposure to particles) and genetic susceptibility factors. The persistence of granulomas is deleterious, ultimately leading to local destruction and tissue damage resulting in fibrosis of neighbouring tissues. Granulomatosis is a heterogeneous group in terms of aetiology: schematically, either an aetiology is identified: infection, environmental factors (berylliosis, pneumoconiosis), iatrogenesis (drugs), neoplasia, immune deficiency; or granulomatosis is said to be idiopathic, the most common case, falling within the definition of systemic sarcoidosis. Therefore, with a view to future research work, it seems imperative to set up a biological bank of patients being monitored for systemic granulomatosis within the division. It is particularly important to identify genetic variants, circulating biomarkers associated with the onset, severity and response to treatment of these diseases. The main aim of the "GRAMI-BIO" study is to describe the clinical evolution of patients with systemic granulomatosis (sarcoidosis and other granulomatoses) followed at the Bordeaux University Hospital, and to collect samples from blood fractionation (serum bank, plasma bank, urine bank, DNA, RNA bank) to constitute a biobank.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Granulomatosis |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| blood sample | Biological | 30 ml whole blood for Peripheral blood mononuclear cell (PBMC) and monocytes isolation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Describe the clinical progression of systemic granulomatosis | At baseline (Day 0) and 60 months after baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Identify predictive factors for the progression of the disease | At baseline (Day 0) and 60 months after baseline | |
| Identify the management methods into patients with systemic granulomatosis | At baseline (Day 0) and 60 months after baseline |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with systemic granulomatosis (diagnosis proven by anatomopathological sampling)
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Emmanuel RIBEIRO, MD | Contact | 05.56.79.58.28 | +33 | emmanuel.ribeiro@chu-bordeaux.fr |
| Jean DELAUNE | Contact | jean.delaune@chu-bordeaux.fr |
| Name | Affiliation | Role |
|---|---|---|
| Emmanuel RIBEIRO, MD | University Hospital, Bordeaux | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU de Bordeaux - service de Médecine Interne et Immunologie Clinique | Recruiting | Bordeaux | France |
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| ID | Term |
|---|---|
| D012507 | Sarcoidosis |
| ID | Term |
|---|---|
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006968 | Hypersensitivity, Delayed |
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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 |
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30 ml whole blood for Peripheral blood mononuclear cell (PBMC) and monocytes isolation and 10 ml urine sample.
| urine sample | Biological | 10 ml |
|
| Identify predictive factors for response to treatments | At baseline (Day 0) and 60 months after baseline |
| Identify new clusters of the disease in a large population both clinically and biologically | At baseline (Day 0) and 60 months after baseline |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |