Clinical trial · Observational
Understanding immunE-related toXicities by multifACeT Profiling
EXACT - Understanding immunE-related toXicities by multifACeT Profiling
NCT05331066CI-TRIAL-00096070EXACTrecruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
A prospective observational cohort study of patients undergoing CPI therapy in which translational research is the fundamental aspect of the study.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Oncology | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Patients who experience irAEs
- timeFrame
- 36 months
- description
- To determine the proportion of patients who experience irAEs during treatment with CPI.
Secondary outcomes (3)
- measure
- Biological and clinical characteristics
- timeFrame
- 60 months
- description
- To profile biological and clinical characteristics at baseline and during treatment with CPI to detect indicators predictive of the development of immunotherapy-related adverse events (irAEs).
- measure
- Time to development of irAEs
- timeFrame
- 36 months
- description
- To determine time to clinical development of irAEs during treatment with CPI.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Written informed consent * Age 18 years or older * Confirmed diagnosis of any form of solid malignancy with a clinical indication and appropriate treatment plan to commence immune checkpoint inhibitor therapy Exclusion Criteria: * Medical or psychological condition that would preclude informed consent * Planned participation in a drug trial receiving investigational agents * Subjects who have previously commenced immune checkpoint inhibitor therapy prior to study entry. * Subjects unable to comply with the study or sample schedule.
References
Publications (0)
Data not yet available
No reference posted for this study.