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ASIA Study : French Register of Inflammatory Eye Disease

ASIA Study: French Register of Inflammatory Eye Disease Secondary to Cancer Immunotherapy

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04760197
Acronym
ASIA
Enrollment
30
Registered
2021-02-18
Start date
2019-04-01
Completion date
2021-12-01
Last updated
2021-02-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients Treated for Cancer by Immunotherapy

Keywords

immune check points inhibitors, cancer, inflammatory ophthalmological manifestations

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.

Interventions

OTHERno intervention

no intervention

Sponsors

Hospices Civils de Lyon
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Clinical evolution of inflammatory ophtalmological manifestation evaluated by gradation of uveitis6 months after diagnosisPersistence of disease is characterized by persistence of intraocular inflammation evaluated by gradation of Uveitis according to Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0, November 2017, National Institutes of Health, National Cancer Institute.

Countries

France

Contacts

Primary ContactFlorence Chaudot, MD
florence.chaudot@chu-lyon.fr4 26 73 26 36
Backup ContactYvan Jamilloux, MD
yvan.jamilloux@chu-lyon.fr4 26 73 26 36

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026