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NCT Number: 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

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

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Key information

Conditions

Hematological Malignancies Hematologic Diseases Hematologic Neoplasms Hemic and Lymphatic Diseases Neoplasms Neoplasms by Site

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Evaluate the incidence, type and severity of immune-related endocrine side effects

    Time frame: 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.

Secondary outcomes

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

    Time frame: through study completion, an average of 2 year

    correlation between patients characteristics and occurrence of immune-mediated endocrine toxicities

  2. impact of toxicity on the continuation of therapy

    Time frame: through study completion, an average of 2 year

    rate of patients who discontinued therapy due to toxicity

  3. monitoring system for early diagnosis and management of toxicities

    Time frame: through study completion, an average of 2 year

    assesment of toxicities since first cycle and comparison with medical history

Study contacts

Contact information is provided by the study sponsor or research team.

Cinzia Pellegrini, MD

CONTACT

[email protected]

+390512143680

Pier Luigi Zinzani, MD

CONTACT

[email protected]

+390512143680

Sponsors and collaborators

Lead sponsor

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Other

Registry information

Acronym: Endemato

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Feb 28, 2025
Registry last updated
Feb 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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