Evaluating endocrine side effects in blood cancer patients treated with immune therapies
Observational Study for the Evaluation of Immune-mediated Endocrinological Adverse Events in Patients With Hematological Malignancies and Subjected to Treatment With Immune-checkpoint Inhibitors
IRCCS Azienda Ospedaliero-Universitaria di Bologna · NCT06851702
This study is testing whether immune therapies for blood cancer can cause hormonal side effects in adults with advanced stages of the disease.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | IRCCS Azienda Ospedaliero-Universitaria di Bologna (other) |
| Locations | 1 site (Bologna, Bologna) |
| Trial ID | NCT06851702 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the occurrence of immune-mediated endocrinological adverse events in patients with hematological malignancies who are being treated with immune-checkpoint inhibitors. It includes both retrospective and prospective cohorts of patients aged over 18 years with advanced stages of blood cancers, specifically those with B or T lymphocyte origin. Participants will provide written informed consent, and the study will analyze the relationship between treatment and the development of endocrine complications.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 years with advanced hematological malignancies who are either currently receiving or are candidates for immune-checkpoint inhibitor therapy.
Not a fit: Patients with severe medical or psychiatric disorders that could interfere with the study results may not benefit from participation.
Why it matters
Potential benefit: If successful, this study could improve the understanding of endocrine side effects in patients receiving immune therapies, leading to better management and care.
How similar studies have performed: While this study focuses on a specific patient population and adverse events, similar studies have shown that understanding side effects of immune therapies can lead to improved patient outcomes.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Bologna, Bologna
- IRCCS Azienda Ospedaliero - Universitaria di Bologna — Bologna, Bologna, Italy (RECRUITING)
Study contacts
- Study coordinator: Pier Luigi Zinzani, MD
- Email: pierluigi.zinzani@unibo.it
- Phone: +390512143680
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Hematological Malignancies, immune-checkpoint inhibitors, endocrinological adverse events