UveitisDeLPHyNCT05388838
Screening for Oculocerebral Lymphoma With the Phenotype of NK Cells in Patients With Uveitis
A study testing Blood sample in people with Uveitis and Lymphoma, run by Hospices Civils de Lyon at 2 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Uveitis, Lymphoma, NK-Cell Lymphoma
- What is being tested?
- Blood sample
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesFrance
- Study dates
- 1 Jun 2022to 17 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- -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,
Show all 10Show fewer
- 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.
Trial locations and contacts
2 sites in 1 country.
France2 sites
Service d'Ophtalmologie, Hôpital de la Croix-Rousse, GHN
Lyon, 69004
Service d'Hématologie Clinique, Hôpital Lyon Sud
Lyon, 69310
About this study
Official title: Screening for Oculocerebral Lymphoma by Identifying the Phenotype Carried by Circulating NK Cells in Patients With Uveitis
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.
Read more
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.
- Conditions
- Uveitis, Lymphoma, NK-Cell Lymphoma
- Being tested
- Blood sample
- Medical subject headings
- Uveitis, Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood sampleBiological
Blood sample will be taken at D0: 63 ml (7 tubes of 9 ml),
| Study group | Role | What they receive |
|---|---|---|
| Negative control | Active comparator | uveitis patients with a diagnosis other than ocular diagnosis other than ocular lymphoma and without cerebral lymphoma (15 patients), Receives: Biological: Blood sample |
| Primary ocular Lymphoma without brain involvementand never treated | Active comparator | patients with primary ocular lymphoma without brain involvement and never treated (5 patients), Receives: Biological: Blood sample |
| 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), Receives: Biological: Blood sample |
| Primary ocular Lymphoma without brain involvement in relapse | Active comparator | patients with primary ocular lymphoma without brain involvement, considered in relapse (5 patients), Receives: Biological: Blood sample |
| Positive control | Active comparator | patients with cerebral lymphoma with or without ocular involvement and without uveitis (15 patients). Receives: Biological: Blood sample |
| 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). Receives: Biological: Blood sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2022
- Study start1 Jun 2022
- Primary completion17 Mar 2025
- Study completion17 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for UveitisStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Prospective Case Control Study
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05388838
- Sponsor's protocol ID
- 69HCL22_0078
- Other IDs
- 2022-A00254-39
- Acronym
- DeLPHy
- Status last verified
- Aug 2026
- First submitted
- 16 May 2022
- Last updated
- 1 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Screening for Oculocerebral Lymphoma by Identifying the Phenotype Carried by Circulating NK Cells in Patients With Uveitis
- ClinicalTrials.gov ID
- NCT05388838
- Acronym / sponsor ID
- DeLPHy / 69HCL22_0078
- Conditions
- Uveitis, Lymphoma, NK-Cell Lymphoma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 17 Mar 2025 (actual)
- Study completion
- 17 Mar 2025 (actual)
- First posted
- 24 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
- Model description
- Prospective Case Control Study
| Arm | Type | Receives |
|---|---|---|
| Negative control | Active comparator | Biological: Blood sampleuveitis 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 | Biological: Blood samplepatients with primary ocular lymphoma without brain involvement and never treated (5 patients), |
| Primary ocular Lymphoma without brain involvement and treated | Active comparator | Biological: Blood samplepatients with primary ocular lymphoma without brain involvement, treated and considered in remission (5 patients), |
| Primary ocular Lymphoma without brain involvement in relapse | Active comparator | Biological: Blood samplepatients with primary ocular lymphoma without brain involvement, considered in relapse (5 patients), |
| Positive control | Active comparator | Biological: Blood samplepatients with cerebral lymphoma with or without ocular involvement and without uveitis (15 patients). |
| Patients without brain involvement and without uveitis | Active comparator | Biological: Blood samplePatients presenting for cataract follow-up (pre- or post-operative), glaucoma, retinal detachment or epiretinal membrane, with no brain damage or uveitis (15 patients). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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).
Key exclusion criteria (10 listed)
- -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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood sampleBlood sample will be taken at D0: 63 ml (7 tubes of 9 ml), | Biological | Negative control, Patients without brain involvement and without uveitis, Positive control, Primary ocular Lymphoma without brain involvement and treated, Primary ocular Lymphoma without brain involvement in relapse, Primary ocular Lymphoma without brain involvementand never treated |
Primary outcome
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)
Time frame: through study completion, an average of 1 year
mesure by Flow Cytometry
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
Time frame: through study completion, an average of 1 year
mesure by Flow Cytometry
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood sample in people with Uveitis and Lymphoma, run by Hospices Civils de Lyon at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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) (time frame: through study completion, an average of 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2026.