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ASIA Study : French Register of Inflammatory Eye Disease

Civil Hospices of Lyon logo

Civil Hospices of Lyon

Status

Unknown

Conditions

Patients Treated for Cancer by Immunotherapy

Treatments

Other: no intervention

Study type

Observational

Funder types

Other

Identifiers

NCT04760197
69HCL20_0136

Details and patient eligibility

About

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.

Enrollment

30 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

30 participants in 1 patient group

patient under cancer immunotherapy with inflammatory ophthalmological manifestations
Description:
patient(\>18 years old) under cancer immunotherapy with inflammatory ophthalmological manifestations
Treatment:
Other: no intervention

Trial contacts and locations

2

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Central trial contact

Yvan Jamilloux, MD; Florence Chaudot, MD

Data sourced from clinicaltrials.gov

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