Patients Treated for Cancer by ImmunotherapyASIANCT04760197
ASIA Study : French Register of Inflammatory Eye Disease
An observational study of Patients Treated for Cancer by Immunotherapy, run by Hospices Civils de Lyon at 2 sites in France.
Trial 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.). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Patients Treated for Cancer by Immunotherapy
- How many people
- 30 participants
- Where
- 2 sitesFrance
- Study dates
- 1 Apr 2019to 1 Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients treated for cancer by immunotherapy
Who may be able to join
- 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
Who cannot join
- NA
Trial locations and contacts
2 sites in 1 country.
France2 sites, 2 recruiting
- Recruiting
CHU Angers - Service de Médecine Interne - Immunologie Clinique
Angers, 49933
Pierre Lozach, MD, 2 41 35 36 37 ext. +33, Pierre.LozacH@chu-angers.fr
- Recruiting
Hôpital de la Croix-Rousse - Service de médecine interne - 103 Grande Rue de la Croix-Rousse
Lyon, 69004
Yvan Jamilloux, MD, 4 26 73 26 36 ext. +33, yvan.jamilloux@chu-lyon.fr
About this study
Official title: 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.
- Being tested
- no intervention
- Keywords
- immune check points" inhibitors, cancer, inflammatory ophthalmological manifestations
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no interventionOther
no intervention
| Study group | Role | What they receive |
|---|---|---|
| patient under cancer immunotherapy with inflammatory ophthalmological manifestations | patient(>18 years old) under cancer immunotherapy with inflammatory ophthalmological manifestations Receives: Other: no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months after diagnosis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2021
- Study start1 Apr 2019
- Primary completion1 Dec 2020
- Study completion1 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patients Treated for Cancer by ImmunotherapyStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Florence Chaudot, MD, Principal investigator, : Hospices Civils de Lyon - Groupement Hospitalier Nord
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04760197
- Sponsor's protocol ID
- 69HCL20_0136
- Acronym
- ASIA
- Status last verified
- Feb 2021
- First submitted
- 16 Feb 2021
- Last updated
- 18 Feb 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ASIA Study: French Register of Inflammatory Eye Disease Secondary to Cancer Immunotherapy
- ClinicalTrials.gov ID
- NCT04760197
- Acronym / sponsor ID
- ASIA / 69HCL20_0136
- Keywords
- immune check points" inhibitors, cancer, inflammatory ophthalmological manifestations
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 1 Apr 2019 (actual)
- Primary completion
- 1 Dec 2020 (actual)
- Study completion
- 1 Dec 2021 (estimated)
- First posted
- 18 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patient under cancer immunotherapy with inflammatory ophthalmological manifestations | – | Other: no interventionpatient(>18 years old) under cancer immunotherapy with inflammatory ophthalmological manifestations |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients treated for cancer by immunotherapy
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- NA
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| no interventionno intervention | Other | patient under cancer immunotherapy with inflammatory ophthalmological manifestations |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2021.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Florence Chaudot, MD principal investigator
: Hospices Civils de Lyon - Groupement Hospitalier Nord
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Patients Treated for Cancer by Immunotherapy, run by Hospices Civils de Lyon at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Florence Chaudot, MD (4 26 73 26 36 ext. +33, florence.chaudot@chu-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical evolution of inflammatory ophtalmological manifestation evaluated by gradation of uveitis (time frame: 6 months after diagnosis). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2021.