ASIA Study : French Register of Inflammatory Eye Disease (ASIA)

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

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.

Study Overview

• Status: Unknown
• Conditions: Patients Treated for Cancer by Immunotherapy
• Intervention / Treatment: Other: no intervention

• Study Type: Observational
• Enrollment (Anticipated): 30

Contacts and Locations

Study Locations

• France
  • Angers, France, 49933
    • Recruiting
    • CHU Angers - Service de Médecine Interne - Immunologie Clinique
    • Contact: Pierre Lozach, MD; Phone Number: +33 2 41 35 36 37; Email: Pierre.LozacH@chu-angers.fr
  • Lyon cedex 04, France, 69004
    • Recruiting
    • Hôpital de la Croix-Rousse - Service de médecine interne - 103 Grande Rue de la Croix-Rousse
    • Contact: Yvan Jamilloux, MD; Phone Number: +33 4 26 73 26 36; Email: yvan.jamilloux@chu-lyon.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

patients treated for cancer by immunotherapy

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
patient under cancer immunotherapy with inflammatory ophthalmological manifestations; patient(>18 years old) under cancer immunotherapy with inflammatory ophthalmological manifestations	Other: no intervention; no intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical evolution of inflammatory ophtalmological manifestation evaluated by gradation of uveitis	Persistence 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.	6 months after diagnosis

Collaborators and Investigators

• Sponsor: Hospices Civils de Lyon
• Investigators: Principal Investigator: Florence Chaudot, MD, : Hospices Civils de Lyon - Groupement Hospitalier Nord

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2019
• Primary Completion (Actual): December 1, 2020
• Study Completion (Anticipated): December 1, 2021

Study Registration Dates

• First Submitted: February 16, 2021
• First Submitted That Met QC Criteria: February 16, 2021
• First Posted (Actual): February 18, 2021

Study Record Updates

• Last Update Posted (Actual): February 18, 2021
• Last Update Submitted That Met QC Criteria: February 16, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: cancer; immune check points" inhibitors; inflammatory ophthalmological manifestations
• Additional Relevant MeSH Terms: Eye Diseases
• Other Study ID Numbers: 69HCL20_0136

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No