Ignite Creation Date:
2025-12-24 @ 5:08 PM
Ignite Modification Date:
2026-01-07 @ 1:34 AM
Study NCT ID:
NCT04791150
Status:
UNKNOWN
Last Update Posted:
2021-05-10
First Post:
2021-03-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Rheumatologic Adverse Events and Cancer Immunotherapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D064420', 'term': 'Drug-Related Side Effects and Adverse Reactions'}], 'ancestors': [{'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 400}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-05-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-05', 'completionDateStruct': {'date': '2022-11-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-05-07', 'studyFirstSubmitDate': '2021-03-05', 'studyFirstSubmitQcDate': '2021-03-05', 'lastUpdatePostDateStruct': {'date': '2021-05-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-03-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-07-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'to determine whether a self-questionnaire completed by a patient treated with immunotherapy can identify more patients with rheumatological side effects related to this treatment, compared to the complaint reported by the patient to the oncologist', 'timeFrame': 'ONE YEAR', 'description': 'number of patients referred to a rheumatology consultation thanks to the answers to the questionnaire compared to the number of patients referred to a consultation (from questionnaire and oncologist)'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Oncology', 'Autoimmunity', 'Arthritis', 'Adverse Drug Event']}, 'descriptionModule': {'briefSummary': 'In this study, every patient with cancer who is going to be treated by immunotherapy will fill in a form. In this form, we try to determine if he presents rheumatologic complications of his immunotherapy. If the patient answers yes to one question on the form, the patient will be see in rheumatologic consultation to explore his clinical signs.\n\nThe number of patients referred in consultation thanks to this questionnaire will be compared to the number of patients who would have been spontaneously referred by the oncologist.\n\nThe aim of this questionnaire is to optimise the management of rheumatological effects secondary to immunotherapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient with cancer needed to be treated by immunotherapy\n\nExclusion Criteria:\n\n* Patient already treated by immunotherapy'}, 'identificationModule': {'nctId': 'NCT04791150', 'briefTitle': 'Rheumatologic Adverse Events and Cancer Immunotherapy', 'organization': {'class': 'OTHER', 'fullName': 'Poitiers University Hospital'}, 'officialTitle': 'Rheumatologic Adverse Events and Immunotherapy in Oncology', 'orgStudyIdInfo': {'id': 'ONCOIMMUNO'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Patient with cancer immunotherapy treatment', 'description': 'All patients starting immunotherapy treatment will complete a questionnaire to identify rheumatological side effects, each time they come for treatment.', 'interventionNames': ['Other: Fill in a form']}], 'interventions': [{'name': 'Fill in a form', 'type': 'OTHER', 'description': 'Patient will have to fill in a form at each perfusion of immunotherapy to tell if they presents rheumatologic clinical signs', 'armGroupLabels': ['Patient with cancer immunotherapy treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '86000', 'city': 'Poitiers', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Debiais Françoise, MD', 'role': 'CONTACT', 'email': 'françoise.debiais@chu-poitiers.fr', 'phone': '0033549444465'}, {'name': 'Bel Alice', 'role': 'CONTACT'}], 'facility': 'C.H.U de Poitiers', 'geoPoint': {'lat': 46.58261, 'lon': 0.34348}}], 'centralContacts': [{'name': 'Francoise Debiais, MD PHD', 'role': 'CONTACT', 'email': 'francoise.debiais@chu-poitiers.fr', 'phone': '00335 49 44 44 65'}, {'name': 'Alice Bel', 'role': 'CONTACT', 'email': 'alice.bel@chu-poitiers.fr'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'NO IPD'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Poitiers University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}