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| ID | Type | Description | Link |
|---|---|---|---|
| 2022-A00254-39 | Other Identifier | ANSM |
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Uveitis is an inflammation of the uvea, an ocular tunic comprising the iris, ciliary body and choroid. This inflammation can also involve other tissues such as the retina, the optic nerve and the aqueous humor. These diseases can result in significant vision loss and account for 10% of all blindness in developed countries, and up to 25% in developing countries. The main difficulty in this pathology is to make the etiological diagnosis, which then allows a specific treatment of the disease. The main etiologie are inflammatory or infectious (sarcoidosis, tuberculosis) but other cancerous etiologies are possible and are of more complicated diagnosis.
Vitreoretinal lymphoma is a subtype of central nervous system lymphoma, which is generally associated with a poor prognosis. It is a diffuse non-Hodgkin's lymphoma, with large B cells. It can be primary ocular (Primary Intra-Ocular Lymphoma - LIOP), without brain involvement, but can also be secondary to central nervous system involvement, which explains the poor prognosis of the disease. Approximately 50-90% of LIOP develop brain involvement within 1-2 years of diagnosis, which encourages early diagnosis to avoid brain involvement as much as possible.
The main obstacle to rapid diagnosis is the difficulty of identifying LIOP. Indeed, the clinical symptoms of this rare disease are often identical to classical uveitis, and the diagnostic means to detect it are invasive and require a trained ophthalmologist and hematologist team. LIOP diagnostic tests are often delay in the management of uveitis and lead to diagnostic erraticity that can last between 4 to 40 months.
The INSERM U1183 unit is developing a diagnostic technology for lymphomas based on the analysis of blood NK cells and their phenotypes including those acquired by trogocytosis (WO/2016/005548).
A rapid, simple, minimally invasive LIOP test using this technology could therefore be propose to all patients presenting with uveitis and whose clinical criteria could match those of LIOP.
The research hypothesis is : Could the diagnostic wandering of patients with primary intraocular lymphoma be reduced by a rapid blood test for NK cell phenotype of patients with uveitis? Following a simple blood test, a rapid LIOP test, using this diagnostic technology, could therefore be proposed to all patients with uveitis and clinical criteria (age, intermediate and posterior location of the uveitis) corresponding to those of LIOP.
The primary objective of this study is to compare the phenotype of circulating NK cells of patient with untreated intraocular lymphoma versus the phenotype of patient with non-cancerous uveitis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Negative control | Active Comparator | uveitis patients with a diagnosis other than ocular diagnosis other than ocular lymphoma and without cerebral lymphoma (15 patients), |
|
| Primary ocular Lymphoma without brain involvementand never treated | Active Comparator | patients with primary ocular lymphoma without brain involvement and never treated (5 patients), |
|
| Primary ocular Lymphoma without brain involvement and treated | Active Comparator | patients with primary ocular lymphoma without brain involvement, treated and considered in remission (5 patients), | |
| Primary ocular Lymphoma without brain involvement in relapse | Active Comparator | patients with primary ocular lymphoma without brain involvement, considered in relapse (5 patients), |
|
| Positive control | Active Comparator | patients with cerebral lymphoma with or without ocular involvement and without uveitis (15 patients). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blood sample | Biological | Blood sample will be taken at D0: 63 ml (7 tubes of 9 ml), |
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| Measure | Description | Time Frame |
|---|---|---|
| percentage of NK Cells in blood with phenotype acquired by trogocytosis (WO/2016/005548) in patients with uveitis with a diagnosis other than ocular lymphoma and without cerebral lymphoma (Negative control) | mesure by Flow Cytometry | through study completion, an average of 1 year |
| percentage of NK Cells in blood with phenotype acquired by trogocytosis (WO/2016/005548) in patients with primary ocular lymphoma without brain involvement and never treated | mesure by Flow Cytometry | through study completion, an average of 1 year |
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Inclusion Criteria:
GENERAL CRITERIA
SPECIFIC CRITERIA
- Patient affected in one or both eyes: of uveitis with another diagnosis than ocular lymphoma and without cerebral lymphoma (Group 1), or primary ocular lymphoma without brain involvement and never treated (Group 2), or primary ocular lymphoma without brain involvement, treated and considered in remission (IL10 HA level < 10) (Group 3), or primary ocular lymphoma without brain involvement, and considered in relapse (IL10 HA level > 30) (Group 4), or cerebral lymphoma with or without ocular involvement and without uveitis (Group 5), or cataract (pre- and post-op), glaucoma, retinal detachment or epiretinal retinal detachment or epiretinal membrane, but no brain damage or uveitis (group 6).
Exclusion Criteria:
SPECIFIC CRITERIA
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Thibaud MATHIS, Dr | Contact | 4 26 10 93 22 | +33 | thibaud.mathis@chu-lyon.fr |
| Christelle SZATANEK, MsC | Contact | 4 26 73 27 24 | +33 | christelle.szatanek@chu-lyon.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Service d'Ophtalmologie, Hôpital de la Croix-Rousse, GHN | Recruiting | Lyon | 69004 | France |
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| ID | Term |
|---|---|
| D014605 | Uveitis |
| D008223 | Lymphoma |
| ID | Term |
|---|---|
| D014603 | Uveal Diseases |
| D005128 | Eye Diseases |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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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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Prospective Case Control Study
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| Patients without brain involvement and without uveitis |
| Active Comparator |
Patients presenting for cataract follow-up (pre- or post-operative), glaucoma, retinal detachment or epiretinal membrane, with no brain damage or uveitis (15 patients). |
|
| Service d'Hématologie Clinique, Hôpital Lyon Sud | Recruiting | Lyon | 69310 | France |
|
| D008232 |
| Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |