Clinical trial · Observational
Observational Study for the Evaluation of Immune-mediated Endocrinological Adverse Events in Patients With Hematological Malignancies and Subjected to Treatment With Immune-checkpoint Inhibitors
NCT06851702CI-TRIAL-00086594EndematorecruitingClinicalTrials.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)
Retrospective / prospective observational study of endocrinological adverse events in hematologic patients treated with immunological checkpoint inhibitors
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 |
|---|---|---|---|
| Hematological Malignancies | Hematopoietic and Lymphoid Cell Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Evaluate the incidence, type and severity of immune-related endocrine side effects
- timeFrame
- through study completion, an average of 2 years
- description
- to evaluate the incidence, type and severity of immune-related endocrine side effects (thyroid disease, hypophysitis, diabetes) in patients treated with ICIs, through haematological-endocrinological management.
Secondary outcomes (3)
- measure
- search for predictive criteria for the appearance of immune-mediated endocrine toxicities
- timeFrame
- through study completion, an average of 2 year
- description
- correlation between patients characteristics and occurrence of immune-mediated endocrine toxicities
- measure
- impact of toxicity on the continuation of therapy
- timeFrame
- through study completion, an average of 2 year
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: Retrospective cohort * patients aged\> 18 years * cyto-histological diagnosis of mature lymphoproliferative syndrome of B or T lymphocyte origin * advanced stage of illness (relapsed or refractory) * patients undergoing treatment with immune anticheckpoint antibodies. * written informed consent Prospective cohort * patients aged\> 18 years * cyto-histological diagnosis of mature lymphoproliferative syndrome of B or T lymphocyte origin * advanced stage of illness (relapsed or refractory) * patients who are candidates for therapy with anticheckpoint immune antibodies (it is specified that this therapy is completely independent of the subject's participation in the study). * written informed consent Exclusion Criteria: * Severe, acute and chronic medical or psychiatric disorders that may affect the interpretation of the study results or interfere with it.
References
Publications (0)
Data not yet available
No reference posted for this study.