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

NCT06851702 | Recruiting

• 1 other identifier: Endemato
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Hematological Malignancies

Keywords

immune-checkpoint inhibitors; endocrinological adverse events

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (3)

• search for predictive criteria for the appearance of immune-mediated endocrine toxicities

  through study completion, an average of 2 year

• impact of toxicity on the continuation of therapy

  through study completion, an average of 2 year

• monitoring system for early diagnosis and management of toxicities

  through study completion, an average of 2 year

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients with hematological malignancies and subjected to treatment with immune-checkpoint inhibitors

You may qualify if:

• 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

You may not qualify if:

• Severe, acute and chronic medical or psychiatric disorders that may affect the interpretation of the study results or interfere with it.

Sponsors & Collaborators

• IRCCS Azienda Ospedaliero-Universitaria di Bologna: lead

Study Sites (1)

IRCCS Azienda Ospedaliero - Universitaria di Bologna

Bologna, Bologna, 40138, Italy

RECRUITING

MeSH Terms

Conditions

Hematologic Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Central Study Contacts

Pier Luigi Zinzani, MD

CONTACT

+390512143680; pierluigi.zinzani@unibo.it

Cinzia Pellegrini, MD

CONTACT

+390512143680; cinzia.pellegrini@aosp.bo.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 29, 2025
• First Posted: February 28, 2025
• Study Start: June 1, 2025
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: February 28, 2025

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)