NCT03868046Completed
Autoantibodies in Treatment with Immune Checkpoint Inhibitors (AUTENTIC)
Prediction of Immune-related Adverse Events Induced by Anti-CTLA4 and Anti-PD1/PDL1 Drugs by Means of a Battery of Autoantibodies. a Multicenter Prospective Observational Cohort Study
Source: ClinicalTrials.gov · Last updated 1 Apr 2025
Brief summary (registry, in English)
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 immune checkpoint inhibitors (ICIs) per standard protocol.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 242 (actual)
- First submitted
- 6 Mar 2019
- Start date
- 25 Aug 2019
- Primary completion date
- 31 Oct 2023
- Lead sponsor
- Hospital Universitario Araba
- Diseases
- Childhood cancers
- NCT number
- NCT03868046
What you commit to
- Study type: Observational
- Participants enrolled: 242
- From 25 Aug 2019 to the primary completion date, 31 Oct 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
- 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.
Other illness
- Active autoimmune disease with severe involvement.
Other
- Eastern Cooperative Oncology Group (ECOG) performance status ≥ 3.
Who the study is looking for
- Initiation of treatment with a single ICI or a combination of ICIs.
- Acceptation of an informed consent.
Age in the registry: 16 years to 99 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hospital Universitario Araba Coordinator of this site? Confirm its status | Vitoria-Gasteiz | Spain | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.