Hematological MalignanciesEndematoNCT06851702
Observational Study for the Evaluation of Immune-mediated Endocrinological Adverse Events in Patients With Hematological Malignancies and Subjected to Treatment With Immune-checkpoint Inhibitors
An observational study of Hematological Malignancies, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 1 site in Italy.
Trial summary
Retrospective / prospective observational study of endocrinological adverse events in hematologic patients treated with immunological checkpoint inhibitors Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hematological Malignancies
- How many people
- 100 participants
- Where
- 1 siteItaly
- Study dates
- Jun 2025to Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients with hematological malignancies and subjected to treatment with immune-checkpoint inhibitors
Who may be able to join
- 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
Show all 12Show fewer
- 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
Who cannot join
- Severe, acute and chronic medical or psychiatric disorders that may affect the interpretation of the study results or interfere with it.
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
IRCCS Azienda Ospedaliero - Universitaria di Bologna
Bologna, Bologna, 40138
Pier Luigi Zinzani, MD, +390512143680, pierluigi.zinzani@unibo.it
Cinzia Pellegrini, MD, +390512143680, cinzia.pellegrini@aosp.bo.it
About this study
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
- Medical subject headings
- Hematologic Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: through study completion, an average of 2 years
Secondary outcomes (3)
search for predictive criteria for the appearance of immune-mediated endocrine toxicities
correlation between patients characteristics and occurrence of immune-mediated endocrine toxicities
Measured: through study completion, an average of 2 year
impact of toxicity on the continuation of therapy
rate of patients who discontinued therapy due to toxicity
Measured: 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
Measured: through study completion, an average of 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2025
- Study startJun 2025 (estimated)
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hematological MalignanciesStudies of the same condition, open and under way.
- More trials run by IRCCS Azienda Ospedaliero-Universitaria di BolognaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06851702
- Sponsor's protocol ID
- Endemato
- Acronym
- Endemato
- Status last verified
- Oct 2024
- First submitted
- 29 Jan 2025
- Last updated
- 28 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Study for the Evaluation of Immune-mediated Endocrinological Adverse Events in Patients With Hematological Malignancies and Subjected to Treatment With Immune-checkpoint Inhibitors
- ClinicalTrials.gov ID
- NCT06851702
- Acronym / sponsor ID
- Endemato / Endemato
- Conditions
- Hematological Malignancies
- Keywords
- immune-checkpoint inhibitors, endocrinological adverse events
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- IRCCS Azienda Ospedaliero-Universitaria di BolognaUniversity, hospital or other
- Study start
- Jun 2025 (estimated)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 28 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Retrospective / prospective observational study of endocrinological adverse events in hematologic patients treated with immunological checkpoint inhibitors
Study design
- Observational model
- Cohort
- Time perspective
- Other
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with hematological malignancies and subjected to treatment with immune-checkpoint inhibitors
Key inclusion criteria (12 listed)
- 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.
Key exclusion criteria (1 listed)
- Severe, acute and chronic medical or psychiatric disorders that may affect the interpretation of the study results or interfere with it.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
3 secondary outcomes
search for predictive criteria for the appearance of immune-mediated endocrine toxicities
Time frame: through study completion, an average of 2 year
impact of toxicity on the continuation of therapy
Time frame: through study completion, an average of 2 year
monitoring system for early diagnosis and management of toxicities
Time frame: through study completion, an average of 2 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hematological Malignancies, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Pier Luigi Zinzani, MD (+390512143680, pierluigi.zinzani@unibo.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate the incidence, type and severity of immune-related endocrine side effects (time frame: through study completion, an average of 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2025.