Ignite Creation Date:
2025-12-24 @ 10:29 PM
Ignite Modification Date:
2026-02-20 @ 11:27 PM
Study NCT ID:
NCT06476535
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-06-26
First Post:
2024-06-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Observatory of Patients With MyeloProliferative Neoplasm Treated With Anti-inflammatory Immunotherapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009196', 'term': 'Myeloproliferative Disorders'}], 'ancestors': [{'id': 'D001855', 'term': 'Bone Marrow Diseases'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2024-06-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2026-05-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-06-25', 'studyFirstSubmitDate': '2024-06-13', 'studyFirstSubmitQcDate': '2024-06-25', 'lastUpdatePostDateStruct': {'date': '2024-06-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-06-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-05-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Efficacy of the anti-inflammatory immunotherapy', 'timeFrame': '1 year', 'description': 'Depending on the indication of the anti-inflammatory treatment, clinical efficacy will be assessed clinically as number of patients reaching complete (total disappearance of initial symptoms- diarrhea, arthritis, fever, skin lesions), partial (improvement of symptoms, but not total disappearance) or absence of response (the treatment did not improve the symptoms). Clinical judgement will be according to the physician appreciation.'}, {'measure': 'Tolerability of the anti-inflammatory immunotherapy', 'timeFrame': '1 year', 'description': 'Tolerability will be assessed as the number of reported unexpected side effects attributed to the treatment as judged by the caring physician, including treatment discontinuation'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Myeloproliferative Neoplasm', 'Inflammatory Disease']}, 'descriptionModule': {'briefSummary': 'The study will collect cases of MPN patients who also benefit from an anti-inflammatory immunotherapy for another disease. Efficacy and tolerability of the drug will be assessed in this population.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'MyeloProliferative Neoplasm patients followed in one of the centres participating to the FIM (French Intergroup- MPN) group', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* MyeloProliferative Neoplasm diagnosis\n* receiving or having received an immunotherapy targeting IL-1, IL-6, IL-17, IL-23 or TNF\n\nExclusion Criteria:\n\n* Unable to consent'}, 'identificationModule': {'nctId': 'NCT06476535', 'acronym': 'OPIUM', 'briefTitle': 'Observatory of Patients With MyeloProliferative Neoplasm Treated With Anti-inflammatory Immunotherapy', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Brest'}, 'officialTitle': 'Observatory of Patients With MyeloProliferative Neoplasm Treated With Anti-inflammatory Immunotherapy', 'orgStudyIdInfo': {'id': '29BRC24.0155 - OPIUM'}}, 'contactsLocationsModule': {'locations': [{'zip': '29609', 'city': 'Brest', 'country': 'France', 'facility': 'Chu Brest', 'geoPoint': {'lat': 48.39029, 'lon': -4.48628}}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': 'Data will be available beginning three years and ending fifteen years following the final study report completion', 'ipdSharing': 'YES', 'description': 'All collected data that underlie results in a publication', 'accessCriteria': 'Data access requests will be reviewed by the internal committee of Brest UH. Requestors will be required to sign and complete a data access agreement'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Brest', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}