NCT05388838: DeLPHy

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

Recruiting now NA Last updated 3 March 2025

What this trial tests

NA trial testing Blood sample in Uveitis in 60 participants. Currently enrolling.

Timeline

1 June 2022

Primary endpoint
1 December 2025

1 December 2025

Quick facts

Lead sponsor	Hospices Civils de Lyon
Phase	NA
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	diagnostic
Enrollment	60
Start date	1 June 2022
Primary completion	1 December 2025
Estimated completion	1 December 2025
Sites	2 locations across France

Drugs / interventions tested

• Blood sample — full drug profile →

Conditions studied

• Uveitis — all drugs for Uveitis →
• Lymphoma — all drugs for Lymphoma →
• NK-Cell Lymphoma — all drugs for NK-Cell Lymphoma →

Sponsor

Hospices Civils de Lyon — full company profile →

Who can join

18 and older, any sex, with Uveitis or Lymphoma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Human retinal secretome: A cross-link between mesenchymal and retinal cells.
   Donato L, Scimone C, Alibrandi S, Scalinci SZ, et al · · 2023 · cited 6× · PMID 37545752 · DOI 10.4252/wjsc.v15.i7.665