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CompletedNCT05388838DeLPHyUpdated Sep 1, 2026

Screening for Oculocerebral Lymphoma With the Phenotype of NK Cells in Patients With Uveitis

An interventional study of Blood sample in Uveitis, Lymphoma and NK-Cell Lymphoma, sponsored by Hospices Civils de Lyon. Completed at 2 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-01.

Sponsored by Hospices Civils de Lyon · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
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Study 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.

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Conditions studied

  • Uveitis
  • Lymphoma
  • NK-Cell Lymphoma

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In context

Uveitis

299 studies on the registry are indexed under Uveitis; 32 are open to participants now.

This study's enrollment of 60 is above the median of 30 across 175 interventional studies indexed under Uveitis.

Browse Uveitis studies →

Lead sponsor

Hospices Civils de Lyon is the lead sponsor of 1,866 studies on the registry; 448 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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).

Exclusion criteria

Exclusion Criteria:

  • -GENERAL CRITERIA
  • Patient participating in an ongoing clinical trial at the time of the inclusion visit,
  • 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.
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Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
60 participants (actual)

Study arms

  • Active comparator
    Negative control

    uveitis patients with a diagnosis other than ocular diagnosis other than ocular lymphoma and without cerebral lymphoma (15 patients),

    Biological: Blood sample

  • Active comparator
    Primary ocular Lymphoma without brain involvementand never treated

    patients with primary ocular lymphoma without brain involvement and never treated (5 patients),

    Biological: Blood sample

  • 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),

    Biological: Blood sample

  • Active comparator
    Primary ocular Lymphoma without brain involvement in relapse

    patients with primary ocular lymphoma without brain involvement, considered in relapse (5 patients),

    Biological: Blood sample

  • Active comparator
    Positive control

    patients with cerebral lymphoma with or without ocular involvement and without uveitis (15 patients).

    Biological: Blood sample

  • 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).

    Biological: Blood sample

Interventions

  • BiologicalBlood sample

    Blood sample will be taken at D0: 63 ml (7 tubes of 9 ml),

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What researchers measure

Primary outcomes

  1. 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

    Time frame: through study completion, an average of 1 year

  2. 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

    Time frame: through study completion, an average of 1 year

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Study locations

2 sites
  • Service d'Ophtalmologie, Hôpital de la Croix-Rousse, GHN
    Lyon, 69004, France
  • Service d'Hématologie Clinique, Hôpital Lyon Sud
    Lyon, 69310, France
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References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 1, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05388838
Responsible party
Sponsor
First posted
May 24, 2022
Start date
Jun 1, 2022
Primary completion
Mar 17, 2025
Completion
Mar 17, 2025
Last update
Sep 1, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

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