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

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ClinicalTrials.gov Identifier: NCT04760197
Recruitment Status : Recruiting
First Posted : February 18, 2021
Last Update Posted : February 18, 2021
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon

Study Description
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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.


Condition or disease Intervention/treatment
Patients Treated for Cancer by Immunotherapy Other: no intervention

Study Design
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Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: ASIA Study: French Register of Inflammatory Eye Disease Secondary to Cancer Immunotherapy
Actual Study Start Date : April 1, 2019
Actual Primary Completion Date : December 1, 2020
Estimated Study Completion Date : December 1, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Diseases

Groups and Cohorts
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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


Outcome Measures
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Primary Outcome Measures :
  1. Clinical evolution of inflammatory ophtalmological manifestation evaluated by gradation of uveitis [ Time Frame: 6 months after diagnosis ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
patients treated for cancer by immunotherapy
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04760197


Contacts
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Contact: Florence Chaudot, MD 4 26 73 26 36 ext +33 florence.chaudot@chu-lyon.fr
Contact: Yvan Jamilloux, MD 4 26 73 26 36 ext +33 yvan.jamilloux@chu-lyon.fr

Locations
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France
CHU Angers - Service de Médecine Interne - Immunologie Clinique Recruiting
Angers, France, 49933
Contact: Pierre Lozach, MD    2 41 35 36 37 ext +33    Pierre.LozacH@chu-angers.fr   
Hôpital de la Croix-Rousse - Service de médecine interne - 103 Grande Rue de la Croix-Rousse Recruiting
Lyon cedex 04, France, 69004
Contact: Yvan Jamilloux, MD    4 26 73 26 36 ext +33    yvan.jamilloux@chu-lyon.fr   
Sponsors and Collaborators
Hospices Civils de Lyon
Investigators
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Principal Investigator: Florence Chaudot, MD : Hospices Civils de Lyon - Groupement Hospitalier Nord
More Information
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Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT04760197    
Other Study ID Numbers: 69HCL20_0136
First Posted: February 18, 2021    Key Record Dates
Last Update Posted: February 18, 2021
Last Verified: February 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hospices Civils de Lyon:
immune check points" inhibitors
cancer
inflammatory ophthalmological manifestations
Additional relevant MeSH terms:
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Eye Diseases