Ignite Creation Date:
2025-12-25 @ 2:10 AM
Ignite Modification Date:
2025-12-30 @ 8:56 AM
Study NCT ID:
NCT06814860
Status:
COMPLETED
Last Update Posted:
2025-02-07
First Post:
2025-01-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Microenvironmental Trial of Classical Hodgkin Lymphoma in Adolescents
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006689', 'term': 'Hodgkin Disease'}], 'ancestors': [{'id': 'D008223', 'term': 'Lymphoma'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Formalin fixed paraffin embedded (FFPE) samples'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 36}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-02-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2024-10-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-02-03', 'studyFirstSubmitDate': '2025-01-02', 'studyFirstSubmitQcDate': '2025-02-03', 'lastUpdatePostDateStruct': {'date': '2025-02-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-02-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-05-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Characterization of the tumour microenvironment', 'timeFrame': 'through study completion, an average of 3 months', 'description': 'Identification of phenotypic markers with possible prognostic and/or therapeutic impact predictive of clinical outcomes in patients undergoing LHC in pediatric/adolescent age.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Hodgkin Lymphoma', 'adolescent', 'microenvironment', 'immune-check points'], 'conditions': ['Classical Hodgkin Lymphoma']}, 'descriptionModule': {'briefSummary': "Background. Classical Hodgkin's lymphoma (cHL) in adolescents between 15 and 18 years shows a higher disease-related mortality and the overall prognosis is worse than both children and adults.\n\nObjectives. To investigate the immune checkpoint inhibitors (ICPI) therapeutic targets and specific T-regulatory and cytotoxic T-cell subsets, in the subgroup of adolescent cHL patients and to investigate their prognostic power.\n\nMethods: Retrieved formalin-fixed paraffin-embedded (FFPE) of adolescent patients diagnosed with cHL with available clinical and tested by immunohistochemistry the immune checkpoint molecules CTLA-4, LAG-3, PD-1 and PDL1 and the biological markers FOXP3 and CD8."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '12 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients aged 12 to 18 years who were histologically diagnosed with Classical Hodgkin lymphoma between 01/01/1996 and 31/12/2020 will be enrolled in the study.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients aged 12 to 18 years at diagnosis of Classical Hodgkin lymphoma.\n\nExclusion Criteria:\n\n* Unavailability/insufficiency of histological material for diagnosis.'}, 'identificationModule': {'nctId': 'NCT06814860', 'acronym': 'LH2004ME', 'briefTitle': 'Microenvironmental Trial of Classical Hodgkin Lymphoma in Adolescents', 'organization': {'class': 'OTHER', 'fullName': 'IRCCS Azienda Ospedaliero-Universitaria di Bologna'}, 'officialTitle': 'Microenvironmental Trial of Classical Hodgkin Lymphoma in Adolescents', 'orgStudyIdInfo': {'id': 'LH2004ME'}, 'secondaryIdInfos': [{'id': 'RC-2022-2773380', 'type': 'OTHER_GRANT', 'domain': 'Ministero della Salute'}]}, 'contactsLocationsModule': {'locations': [{'zip': '40138', 'city': 'Bologna', 'state': 'Bologna', 'country': 'Italy', 'facility': 'IRCCS Azienda Ospedaliero-Universitaria di Bologna', 'geoPoint': {'lat': 44.49381, 'lon': 11.33875}}], 'overallOfficials': [{'name': 'Elena Sabattini, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'IRCCS Azienda Ospedaliero-Universitaria di Bologna'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'IRCCS Azienda Ospedaliero-Universitaria di Bologna', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}