Observational Study for the Evaluation of Immune-mediated Endocrinological Adverse Events in Patients With Hematological Malignancies and Subjected to Treatment With Immune-checkpoint Inhibitors
Retrospective / prospective observational study of endocrinological adverse events in hematologic patients treated with immunological checkpoint inhibitors
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.
Primary outcome measure(s)
Evaluate the incidence, type and severity of immune-related endocrine side effects — through study completion, an average of 2 years 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.
Trial sites (1)
Facility
City
Region
Status
IRCCS Azienda Ospedaliero - Universitaria di Bologna
Bologna
Bologna
Recruiting
More IRCCS Azienda Ospedaliero-Universitaria di Bologna trials in Italy
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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