Screening for Oculocerebral Lymphoma by Identifying the Phenotype Carried by Circulating NK Cells in Patients with Uveitis

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

⁃ GENERAL CRITERIA

• Male or female over 18 years of age,

• Free, informed, written consent signed by the patient and the investigator (at the latest on the day of inclusion) and before any examination required by the research,

• Patient affiliated to the social security system or beneficiary of such a system,

• Maximum volume of sampling (care + research) per 30-day period to be adapted according to the patient's weight (Order of April 12, 2018 establishing the list of research mentioned in 2° of Article L. 1121-1).

⁃ 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).

Locations
Other Locations
France
Service d'Hématologie Clinique, Hôpital Lyon Sud
RECRUITING
Lyon
Service d'Ophtalmologie, Hôpital de la Croix-Rousse, GHN
RECRUITING
Lyon
Contact Information
Primary
Thibaud MATHIS, Dr
thibaud.mathis@chu-lyon.fr
4 26 10 93 22
Backup
Christelle SZATANEK, MsC
christelle.szatanek@chu-lyon.fr
4 26 73 27 24
Time Frame
Start Date: 2022-06-01
Estimated Completion Date: 2025-12-01
Participants
Target number of participants: 60
Treatments
Active_comparator: Negative control
uveitis patients with a diagnosis other than ocular diagnosis other than ocular lymphoma and without cerebral lymphoma (15 patients),
Active_comparator: Primary ocular Lymphoma without brain involvementand never treated
patients with primary ocular lymphoma without brain involvement and never treated (5 patients),
Active_comparator: Primary ocular Lymphoma without brain involvement and treated
patients with primary ocular lymphoma without brain involvement, treated and considered in remission (5 patients),
Active_comparator: Primary ocular Lymphoma without brain involvement in relapse
patients with primary ocular lymphoma without brain involvement, considered in relapse (5 patients),
Active_comparator: Positive control
patients with cerebral lymphoma with or without ocular involvement and without uveitis (15 patients).
Active_comparator: Patients without brain involvement and without uveitis
Patients presenting for cataract follow-up (pre- or post-operative), glaucoma, retinal detachment or epiretinal membrane, with no brain damage or uveitis (15 patients).
Related Therapeutic Areas
Sponsors
Leads: Hospices Civils de Lyon

This content was sourced from clinicaltrials.gov