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

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Other
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: No
View:

• 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

Locations
Other Locations
France
CHU Angers - Service de Médecine Interne - Immunologie Clinique
Recruiting
Angers
Hôpital de la Croix-Rousse - Service de médecine interne - 103 Grande Rue de la Croix-Rousse
Recruiting
Lyon Cedex 04
Contact Information
Primary
Florence Chaudot, MD
florence.chaudot@chu-lyon.fr
4 26 73 26 36
Backup
Yvan Jamilloux, MD
yvan.jamilloux@chu-lyon.fr
4 26 73 26 36
Time Frame
Start Date: April 1, 2019
Estimated Completion Date: December 1, 2021
Participants
Target number of participants: 30
Treatments
patient under cancer immunotherapy with inflammatory ophthalmological manifestations
patient(>18 years old) under cancer immunotherapy with inflammatory ophthalmological manifestations
Authors
Florence Chaudot
Sponsors
Leads: Hospices Civils de Lyon

This content was sourced from clinicaltrials.gov

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