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

Primary Purpose

Uveitis, Lymphoma, NK-Cell Lymphoma

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Blood sample
Sponsored by
Hospices Civils de Lyon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Uveitis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

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.

Sites / Locations

  • Service d'Ophtalmologie, Hôpital de la Croix-Rousse, GHNRecruiting
  • Service d'Hématologie Clinique, Hôpital Lyon SudRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

Negative control

Primary ocular Lymphoma without brain involvementand never treated

Primary ocular Lymphoma without brain involvement and treated

Primary ocular Lymphoma without brain involvement in relapse

Positive control

Arm Description

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

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

patients with primary ocular lymphoma without brain involvement, treated and considered in remission (5 patients),

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

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

Outcomes

Primary Outcome Measures

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
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

Secondary Outcome Measures

Full Information

First Posted
May 16, 2022
Last Updated
December 23, 2022
Sponsor
Hospices Civils de Lyon
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1. Study Identification

Unique Protocol Identification Number
NCT05388838
Brief Title
Screening for Oculocerebral Lymphoma With the Phenotype of NK Cells in Patients With Uveitis
Acronym
DeLPHy
Official Title
Screening for Oculocerebral Lymphoma by Identifying the Phenotype Carried by Circulating NK Cells in Patients With Uveitis
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 1, 2022 (Actual)
Primary Completion Date
June 1, 2023 (Anticipated)
Study Completion Date
June 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospices Civils de Lyon

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Uveitis, Lymphoma, NK-Cell Lymphoma

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Prospective Case Control Study
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
45 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Negative control
Arm Type
Active Comparator
Arm Description
uveitis patients with a diagnosis other than ocular diagnosis other than ocular lymphoma and without cerebral lymphoma (15 patients),
Arm Title
Primary ocular Lymphoma without brain involvementand never treated
Arm Type
Active Comparator
Arm Description
patients with primary ocular lymphoma without brain involvement and never treated (5 patients),
Arm Title
Primary ocular Lymphoma without brain involvement and treated
Arm Type
Active Comparator
Arm Description
patients with primary ocular lymphoma without brain involvement, treated and considered in remission (5 patients),
Arm Title
Primary ocular Lymphoma without brain involvement in relapse
Arm Type
Active Comparator
Arm Description
patients with primary ocular lymphoma without brain involvement, considered in relapse (5 patients),
Arm Title
Positive control
Arm Type
Active Comparator
Arm Description
patients with cerebral lymphoma with or without ocular involvement and without uveitis (15 patients).
Intervention Type
Biological
Intervention Name(s)
Blood sample
Intervention Description
Blood sample will be taken at D0: 63 ml (7 tubes of 9 ml),
Primary Outcome Measure Information:
Title
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)
Description
mesure by Flow Cytometry
Time Frame
through study completion, an average of 1 year
Title
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
Description
mesure by Flow Cytometry
Time Frame
through study completion, an average of 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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). 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Thibaud MATHIS, Dr
Phone
4 26 10 93 22
Ext
+33
Email
thibaud.mathis@chu-lyon.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Christelle SZATANEK, MsC
Phone
4 26 73 27 24
Ext
+33
Email
christelle.szatanek@chu-lyon.fr
Facility Information:
Facility Name
Service d'Ophtalmologie, Hôpital de la Croix-Rousse, GHN
City
Lyon
ZIP/Postal Code
69004
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Thibaud MATHIS, Dr
Phone
4 26 10 93 22
Ext
+33
Email
thibaud.mathis@chu-lyon.fr
First Name & Middle Initial & Last Name & Degree
Christelle SZATANEK, MsC
Phone
4 26 73 27 24
Ext
+33
Email
christelle.szatanek@chu-lyon.fr
First Name & Middle Initial & Last Name & Degree
Thibaud MATHIS, Dr
Facility Name
Service d'Hématologie Clinique, Hôpital Lyon Sud
City
Lyon
ZIP/Postal Code
69310
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hervé GHESQUIERES, Pr
Phone
04.78.86.43.05
Ext
+33
Email
herve.ghesquieres@chu-lyon.fr
First Name & Middle Initial & Last Name & Degree
Hervé GHESQUIERES, Pr

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

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