Recruiting NCT06851702
Observational Study for the Evaluation of Immune-mediated Endocrinological Adverse Events in Patients With Hematological Malignancies and Subjected to Treatment With Immune-checkpoint Inhibitors
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Hematological Malignancies. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
Retrospective / prospective observational study of endocrinological adverse events in hematologic patients treated with immunological checkpoint inhibitors
Primary outcome measures
- Evaluate the incidence, type and severity of immune-related endocrine side effects [Time frame: through study completion, an average of 2 years]
Secondary outcome measures (3)
- search for predictive criteria for the appearance of immune-mediated endocrine toxicities [Time frame: through study completion, an average of 2 year]
- impact of toxicity on the continuation of therapy [Time frame: through study completion, an average of 2 year]
- monitoring system for early diagnosis and management of toxicities [Time frame: through study completion, an average of 2 year]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Italy · 1 center
- IRCCS Azienda Ospedaliero - Universitaria di Bologna — Bologna
Identifiers
NCT: NCT06851702 · Endemato