Screening for Oculocerebral Lymphoma with the Phenotype of NK Cells in Patients with Uveitis
DeLPHy
2 other identifiers
interventional
60
1 country
2
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jun 2022
Longer than P75 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 16, 2022
CompletedFirst Posted
Study publicly available on registry
May 24, 2022
CompletedStudy Start
First participant enrolled
June 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2025
CompletedMarch 3, 2025
February 1, 2025
3.5 years
May 16, 2022
February 28, 2025
Conditions
Outcome Measures
Primary Outcomes (2)
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
Study Arms (6)
Negative control
ACTIVE COMPARATORuveitis 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 COMPARATORpatients with primary ocular lymphoma without brain involvement and never treated (5 patients),
Primary ocular Lymphoma without brain involvement and treated
ACTIVE COMPARATORpatients with primary ocular lymphoma without brain involvement, treated and considered in remission (5 patients),
Primary ocular Lymphoma without brain involvement in relapse
ACTIVE COMPARATORpatients with primary ocular lymphoma without brain involvement, considered in relapse (5 patients),
Positive control
ACTIVE COMPARATORpatients with cerebral lymphoma with or without ocular involvement and without uveitis (15 patients).
Patients without brain involvement and without uveitis
ACTIVE COMPARATORPatients presenting for cataract follow-up (pre- or post-operative), glaucoma, retinal detachment or epiretinal membrane, with no brain damage or uveitis (15 patients).
Interventions
Blood sample will be taken at D0: 63 ml (7 tubes of 9 ml),
Eligibility Criteria
You may qualify if:
- GENERAL CRITERIA
- Male or female over 18 years of age,
- 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).
You may not qualify if:
- GENERAL CRITERIA
- Pregnant women, women in labor or nursing mothers,
- Persons deprived of liberty by a judicial or administrative decision,
- Persons under psychiatric care,
- Persons admitted to a health or social institution for purposes other than research,
- Persons of full age who are subject to a legal protection measure (guardianship, curatorship).
- SPECIFIC CRITERIA
- Patient for whom the diagnosis of ocular or cerebral lymphoma is uncertain,
- Patient with another systemic cancer that is evolving or in remission \< 2 years.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Service d'Ophtalmologie, Hôpital de la Croix-Rousse, GHN
Lyon, 69004, France
Service d'Hématologie Clinique, Hôpital Lyon Sud
Lyon, 69310, France
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 16, 2022
First Posted
May 24, 2022
Study Start
June 1, 2022
Primary Completion
December 1, 2025
Study Completion
December 1, 2025
Last Updated
March 3, 2025
Record last verified: 2025-02