Advanced Cancer Clinical Trial
Official title:
Retrospective Observational Study on the Safety of Immune Checkpoint Inhibitors in the Treatment of Advanced Melanoma and Lung Cancers in Patients With Pre-Existing Autoimmune Diseases
NCT number | NCT03140137 |
Other study ID # | CHECKAUTO |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | January 21, 2017 |
Est. completion date | January 4, 2018 |
Verified date | April 2019 |
Source | University Hospital, Brest |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
The tolerance of immune checkpoint inhibitors is unknown in patients with pre-existing autoimmune conditions. This retrospective nation-wide study will assess their tolerance in patients with pre-existing autoimmune conditions who received immune checkpoint inhibitors for an advanced cancer in clinical practice.
Status | Completed |
Enrollment | 112 |
Est. completion date | January 4, 2018 |
Est. primary completion date | January 4, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Pre-existing autoimmune disease as diagnosed by the physician - Immune checkpoint inhibitor therapy for an advanced cancer Exclusion Criteria: - Auto-immune disease developed only after the start of the immune checkpoint inhibitor therapy - Absence of follow-up |
Country | Name | City | State |
---|---|---|---|
France | CH d'AIX | AIX en PROVENCE | |
France | CHU de DIJON | Dijon | |
France | CHD Vendée | La Roche-sur-Yon | |
France | Ch Le Mans | Le Mans | |
France | CH de MACON | Macon |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Brest |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Autoimmune disease flare | Increase in the activity of the pre-existing autoimmune disease as assessed by the treating physician | through study completion, an average of 1 year | |
Secondary | Other immune/inflammatory complications | Development of a new immune/inflammatory condition after the start of the therapy | through study completion, an average of 1 year |
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