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Retrospective / prospective observational study of endocrinological adverse events in hematologic patients treated with immunological checkpoint inhibitors
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| Measure | Description | Time Frame |
|---|---|---|
| Evaluate the incidence, type and severity of immune-related endocrine side effects | 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. | through study completion, an average of 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| search for predictive criteria for the appearance of immune-mediated endocrine toxicities | correlation between patients characteristics and occurrence of immune-mediated endocrine toxicities | through study completion, an average of 2 year |
| impact of toxicity on the continuation of therapy |
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Inclusion Criteria:
Retrospective cohort
Prospective cohort
Exclusion Criteria:
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patients with hematological malignancies and subjected to treatment with immune-checkpoint inhibitors
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Pier Luigi Zinzani, MD | Contact | +390512143680 | pierluigi.zinzani@unibo.it | |
| Cinzia Pellegrini, MD | Contact | +390512143680 | cinzia.pellegrini@aosp.bo.it |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IRCCS Azienda Ospedaliero - Universitaria di Bologna | Recruiting | Bologna | Bologna | 40138 | Italy |
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rate of patients who discontinued therapy due to toxicity |
| through study completion, an average of 2 year |
| monitoring system for early diagnosis and management of toxicities | assesment of toxicities since first cycle and comparison with medical history | through study completion, an average of 2 year |
| ID | Term |
|---|---|
| D019337 | Hematologic Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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