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Early Detection of Immunotherapy-mediated Toxicity

Early Detection of Immunotherapy-mediated Toxicity

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON23691
Enrollment
50
Registered
2021-05-19
Start date
2021-07-01
Completion date
Unknown
Last updated
2025-02-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

melanoma, renal cell carcinoma, autoinflammatory diseases

Interventions

None listed

Sponsors

Erasmus MC
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Population with immunotherapy-related organ specific toxicity ? Planned treatment with (intravenous) checkpoint inhibitors for any type of cancer according to standard of care. ? Age =18 years ? Able to understand the written information and able to give informed consent 2. Population with immune-mediated organ specific disease ? Patients with immune-mediated organ specific disease including, but not limited to, immune-mediated colitis such as ulcerative colitis, Crohn’s disease or auto-immune hepatitis ? Age =18 years ? Able to understand the written information and able to give informed consent

Exclusion criteria

Exclusion criteria: 4.2 Exclusion criteria ? Unable to draw blood for study purposes

Design outcomes

Primary

MeasureTime frame
The primary study endpoint is the detection of organspecific methylation patterns in cell-free DNA during an irAE.

Secondary

MeasureTime frame
Secondary endpoints are the levels of other biomarkers of inflammation during immunotherapy-mediated toxicity and the comparison organ-specific methylation profiles in blood with other biomarkers of inflammation.

Contacts

Public ContactManouk Bos

Erasmus MC

m.k.bos@erasmusmc.nl00317044375

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)