Observational Study for the Evaluation of Immune-mediated Endocrinological Adverse Events in Patients With Hematological Malignancies and Subjected to Treatment With Immune-checkpoint Inhibitors

NCT ID: NCT06851702

Last Updated: 2025-02-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-06-30

Study Completion Date

2025-12-31

Brief Summary

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Retrospective / prospective observational study of endocrinological adverse events in hematologic patients treated with immunological checkpoint inhibitors

Detailed Description

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Conditions

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Hematological Malignancies

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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IRCCS Azienda Ospedaliero-Universitaria di Bologna

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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IRCCS Azienda Ospedaliero - Universitaria di Bologna

Bologna, Bologna, Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Pier Luigi Zinzani, MD

Role: CONTACT

+390512143680

Cinzia Pellegrini, MD

Role: CONTACT

+390512143680

Facility Contacts

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Pier Luigi Zinzani, MD

Role: primary

+390512143680

Cinzia Pellegrini, MD

Role: backup

+390512143680

Other Identifiers

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Endemato

Identifier Type: -

Identifier Source: org_study_id

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