Ignite Creation Date:
2025-12-25 @ 4:06 AM
Ignite Modification Date:
2025-12-26 @ 3:02 AM
Study NCT ID:
NCT06851702
Status:
RECRUITING
Last Update Posted:
2025-02-28
First Post:
2025-01-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief 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
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019337', 'term': 'Hematologic Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-06', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-24', 'studyFirstSubmitDate': '2025-01-29', 'studyFirstSubmitQcDate': '2025-02-24', 'lastUpdatePostDateStruct': {'date': '2025-02-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-02-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evaluate the incidence, type and severity of immune-related endocrine side effects', 'timeFrame': 'through study completion, an average of 2 years', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'search for predictive criteria for the appearance of immune-mediated endocrine toxicities', 'timeFrame': 'through study completion, an average of 2 year', 'description': 'correlation between patients characteristics and occurrence of immune-mediated endocrine toxicities'}, {'measure': 'impact of toxicity on the continuation of therapy', 'timeFrame': 'through study completion, an average of 2 year', 'description': 'rate of patients who discontinued therapy due to toxicity'}, {'measure': 'monitoring system for early diagnosis and management of toxicities', 'timeFrame': 'through study completion, an average of 2 year', 'description': 'assesment of toxicities since first cycle and comparison with medical history'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['immune-checkpoint inhibitors', 'endocrinological adverse events'], 'conditions': ['Hematological Malignancies']}, 'descriptionModule': {'briefSummary': 'Retrospective / prospective observational study of endocrinological adverse events in hematologic patients treated with immunological checkpoint inhibitors'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'patients with hematological malignancies and subjected to treatment with immune-checkpoint inhibitors', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\nRetrospective cohort\n\n* patients aged\\> 18 years\n* cyto-histological diagnosis of mature lymphoproliferative syndrome of B or T lymphocyte origin\n* advanced stage of illness (relapsed or refractory)\n* patients undergoing treatment with immune anticheckpoint antibodies.\n* written informed consent\n\nProspective cohort\n\n* patients aged\\> 18 years\n* cyto-histological diagnosis of mature lymphoproliferative syndrome of B or T lymphocyte origin\n* advanced stage of illness (relapsed or refractory)\n* 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).\n* written informed consent\n\nExclusion Criteria:\n\n* Severe, acute and chronic medical or psychiatric disorders that may affect the interpretation of the study results or interfere with it."}, 'identificationModule': {'nctId': 'NCT06851702', 'acronym': 'Endemato', 'briefTitle': 'Observational Study for the Evaluation of Immune-mediated Endocrinological Adverse Events in Patients With Hematological Malignancies and Subjected to Treatment With Immune-checkpoint Inhibitors', 'organization': {'class': 'OTHER', 'fullName': 'IRCCS Azienda Ospedaliero-Universitaria di Bologna'}, 'officialTitle': 'Observational Study for the Evaluation of Immune-mediated Endocrinological Adverse Events in Patients With Hematological Malignancies and Subjected to Treatment With Immune-checkpoint Inhibitors', 'orgStudyIdInfo': {'id': 'Endemato'}}, 'contactsLocationsModule': {'locations': [{'zip': '40138', 'city': 'Bologna', 'state': 'Bologna', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Pier Luigi Zinzani, MD', 'role': 'CONTACT', 'email': 'pierluigi.zinzani@unibo.it', 'phone': '+390512143680'}, {'name': 'Cinzia Pellegrini, MD', 'role': 'CONTACT', 'email': 'cinzia.pellegrini@aosp.bo.it', 'phone': '+390512143680'}, {'name': 'Pier Luigi Zinzani, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'IRCCS Azienda Ospedaliero - Universitaria di Bologna', 'geoPoint': {'lat': 44.49381, 'lon': 11.33875}}], 'centralContacts': [{'name': 'Pier Luigi Zinzani, MD', 'role': 'CONTACT', 'email': 'pierluigi.zinzani@unibo.it', 'phone': '+390512143680'}, {'name': 'Cinzia Pellegrini, MD', 'role': 'CONTACT', 'email': 'cinzia.pellegrini@aosp.bo.it', 'phone': '+390512143680'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'IRCCS Azienda Ospedaliero-Universitaria di Bologna', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}