ASIA Study : French Register of Inflammatory Eye Disease
ASIA
ASIA Study: French Register of Inflammatory Eye Disease Secondary to Cancer Immunotherapy
1 other identifier
observational
30
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Apr 2019
Typical duration for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2020
CompletedFirst Submitted
Initial submission to the registry
February 16, 2021
CompletedFirst Posted
Study publicly available on registry
February 18, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2021
CompletedFebruary 18, 2021
February 1, 2021
1.7 years
February 16, 2021
February 16, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Study Arms (1)
patient under cancer immunotherapy with inflammatory ophthalmological manifestations
patient(\>18 years old) under cancer immunotherapy with inflammatory ophthalmological manifestations
Interventions
no intervention
Eligibility Criteria
patients treated for cancer by immunotherapy
You may qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
CHU Angers - Service de Médecine Interne - Immunologie Clinique
Angers, 49933, France
Hôpital de la Croix-Rousse - Service de médecine interne - 103 Grande Rue de la Croix-Rousse
Lyon, 69004, France
MeSH Terms
Conditions
Study Officials
- PRINCIPAL INVESTIGATOR
Florence Chaudot, MD
: Hospices Civils de Lyon - Groupement Hospitalier Nord
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 16, 2021
First Posted
February 18, 2021
Study Start
April 1, 2019
Primary Completion
December 1, 2020
Study Completion
December 1, 2021
Last Updated
February 18, 2021
Record last verified: 2021-02