Status:
COMPLETED
Autoantibodies in Treatment with Immune Checkpoint Inhibitors (AUTENTIC)
Lead Sponsor:
Hospital Universitario Araba
Collaborating Sponsors:
Hospital de Basurto
Hospital Donostia
Conditions:
Cancer
Metastatic Cancer
Eligibility:
All Genders
16-99 years
Brief Summary
The aim of this study is to assess the effectiveness of a battery of autoantibodies to predict the occurrence of immune-related adverse events (irAEs) in patients with cancer who will be treated with ...
Detailed Description
Introduction: Treatment with ICIs is leading to a remarkable improvement in the prognosis of several types of cancer. However, the expansion of these drugs in the field of oncology is also causing the...
Eligibility Criteria
Inclusion
- Initiation of treatment with a single ICI or a combination of ICIs.
- Acceptation of an informed consent.
Exclusion
- Life expectancy lower than 3 months from the initiation of treatment with ICIs.
- Proven hypersensitivity or previous allergic anaphylactic reaction induced by a specific ICI.
- Active autoimmune disease with severe involvement.
- Eastern Cooperative Oncology Group (ECOG) performance status ≥ 3.
- Ongoing immunosuppressive therapy: prednisone at doses \>10 mg/day or equivalent (\>1.5 mg/day of dexamethasone), and/or any dose of azathioprine, methotrexate, mycophenolate, cyclophosphamide, leflunomide, rituximab, anti-tumor necrosis factor drugs (infliximab, etanercept, adalimumab, golimumab), belimumab and abatacept.
Key Trial Info
Start Date :
August 25 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 31 2023
Estimated Enrollment :
242 Patients enrolled
Trial Details
Trial ID
NCT03868046
Start Date
August 25 2019
End Date
December 31 2023
Last Update
April 1 2025
Active Locations (1)
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1
Hospital Universitario Araba
Vitoria-Gasteiz, Álava, Spain, 01009