Clinical trial NCT04760197: ASIA Study : French Register of Inflammatory Eye Disease
Official title: ASIA Study: French Register of Inflammatory Eye Disease Secondary to Cancer Immunotherapy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Patients Treated for Cancer by Immunotherapy
Keywords: immune check points" inhibitors
cancer
inflammatory ophthalmological manifestations
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2021-02-18
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients treated for cancer by immunotherapy

Brief summary: New anticancer therapies based on lifting the inhibition of the immunological synapse are used in the therapeutic arsenal of a growing number of neoplasias (melanoma, lung cancer, hepatocellular carcinoma, etc.). These "immune check points" inhibitors "(ICPI) target molecules that usually allow immunity to destroy malignant cells. At the systemic level, this results in a loss of immune homeostasis and facilitation of the inflammatory response which may be responsible for dysimmune manifestations distant from the neoplastic site. Thus, since their introduction, ICPIs have been of interest to immunologists, rheumatologists and internists who often find themselves in the first line to deal with this type of side effect (immunotherapy-related adverse events, IRAEs). The frequency of these ARIs between 70% and 90%, depending on the immunotherapy used and the severity of these ARIIs (grade 1-2 vs. 3-5). The overall increase in the number of cancers, the multiplication of available molecules and the expansion of their indications should exponentially increase the number of IRAEs to be supported. Little is known about the epidemiology, risk factors and efficacy of treatments.

In these IRAEs, inflammatory ophthalmological manifestations have been described with an estimated prevalence of between 0.4 and 1% of the patients treated. These attacks are rare and protean (uveitis, scleritis, retinitis, inflammatory orbitopathies, Vogt-Koyanagi-Harada -like...) and reported most often in the form of clinical cases.

The Main objective is to describe the inflammatory ophthalmic disorders linked to anti-cancer immunotherapy.


Eligibility criteria: Inclusion Criteria:

* age\> 18
* under cancer immunotherapy: anti-PD1 (nivolumab, pembrolizumab), anti-CTLA4 (ipilimumab), anti-PDL1 (atezolizumab, durvalumab, avelumab)
* diagnosis of uveitis / inflammatory ophthalmologic disease confirmed by at least an ophthalmologist
* indicating his/her non-opposition to participating in the study

Exclusion Criteria:

* NA

Primary outcomes:
measure: Clinical evolution of inflammatory ophtalmological manifestation evaluated by gradation of uveitis
timeFrame: 6 months after diagnosis
Secondary outcomes:
Other outcomes:
Locations:
city: Angers
country: France
facility: CHU Angers - Service de Médecine Interne - Immunologie Clinique
city: Lyon cedex 04
country: France
facility: Hôpital de la Croix-Rousse - Service de médecine interne - 103 Grande Rue de la Croix-Rousse
Study officials:
affiliation: : Hospices Civils de Lyon - Groupement Hospitalier Nord
name: Florence Chaudot, MD
role: PRINCIPAL_INVESTIGATOR
References: