Ignite Creation Date:
2025-12-24 @ 11:53 AM
Ignite Modification Date:
2025-12-29 @ 3:01 PM
Study NCT ID:
NCT05082961
Status:
RECRUITING
Last Update Posted:
2024-12-11
First Post:
2021-10-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Circulating Immunes Cells, Cytokines and Brain Radiotherapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006258', 'term': 'Head and Neck Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-01-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2028-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-12-06', 'studyFirstSubmitDate': '2021-10-06', 'studyFirstSubmitQcDate': '2021-10-06', 'lastUpdatePostDateStruct': {'date': '2024-12-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-10-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'CD8+ T-cell count.', 'timeFrame': 'up to 3 months'}], 'secondaryOutcomes': [{'measure': 'CD4+ Lymphocytes T count', 'timeFrame': 'up to 3 months'}, {'measure': 'Regulatory T cells', 'timeFrame': 'up to 3 months'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Head and Neck Cancer']}, 'referencesModule': {'references': [{'pmid': '39369231', 'type': 'DERIVED', 'citation': 'Thariat J, Pham TN, Coupey J, Clarisse B, Grellard JM, Rousseau N, Cesaire M, Valable S. CYRAD: a translational study assessing immune response to radiotherapy by photons or protons in postoperative head and neck cancer patients through circulating leukocyte subpopulations and cytokine levels. BMC Cancer. 2024 Oct 5;24(1):1230. doi: 10.1186/s12885-024-13002-1.'}]}, 'descriptionModule': {'briefSummary': 'Patients with malignant tumours of the cephalic pole have a poor prognosis, despite a wide range of treatments. prognosis despite a large therapeutic arsenal. Among this arsenal, radiotherapy (RT) is one of the standard treatments for these tumours. However, this treatment can cause damage to the surrounding healthy tissue, has limited efficacy in hypoxic However, this treatment can cause damage to the surrounding healthy tissue, has limited efficacy in hypoxic tissue and can promote pro-tumour inflammation.\n\nIn these circumstances, hadrontherapy, which uses charged heavy particles, such as protons or carbon ions, is the preferred treatment. protons or carbon ions, seems more appropriate for the treatment of these tumours. However, although inflammation plays a major role in tumour development and tumour development and therapeutic response, few studies have evaluated the immune response response after proton therapy (PT) and carbon therapy (CT). The objective of this project is to study the effect of hadrontherapy on resident/circulating inflammation after brain irradiation. brain irradiation. In a first step, the impact of different PT and CT TEL on macrophages (M\\Ф), the most abundant immune cells in malignant solid tumours, will be evaluated in vitro. malignant solid tumours, will be evaluated in vitro. In a second step, the evolution of circulating leukocytes after brain irradiation with X-rays or protons will be studied in vivo in rodents and patients. rodent and patient. In this project, we propose to study for the first time the inflammatory response after hadrontherapy in the context of a cephalic tumour. cephalic tumour. These results will allow a better understanding of the biological response response following PT and CT with the aim of optimising RT and potentially and potentially translate these data to the clinic.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients \\> 18 years\n* Head and neck cancer: (upper aerodigestive tract, cavum, facial sinus, skull base, brain) operated\n* Surgery for complete tumour resection or with microscopic residue R1\n* All possible histologies: squamous cell carcinoma, undifferentiated carcinoma of the nasopharyngeal type (UCNT), adenocarcinoma, adenoid cystic carcinoma, chordoma, chondrosarcoma,meningioma other tumours\n* Patients undergoing exclusive postoperative radiotherapy with a minimum total dose of 54 Gy of X-ray photon radiation or equivalent proton radiation.\n* Patient affiliated to a social security scheme\n* Signature of the informed consent before any specific procedure related to the study\n\nExclusion Criteria:\n\n* Macroscopic postoperative tumour residue R2\n* Previous cancer within 5 years (except treated basal cell skin carcinoma and treated cervical cancer).\n* Previous radiotherapy (except brachytherapy of the cervix or prostate)\n* Chemotherapy or other systemic oncological treatment (cetuximab) concomitant with radiotherapy\n* Long-term immunosuppressive or corticosteroid therapy\n* Patient deprived of liberty or under guardianship, protected adult\n* Patient unable to undergo trial monitoring for geographical, social or psychopathological reasons\n* Pregnant or breastfeeding woman\n* Emergency situations'}, 'identificationModule': {'nctId': 'NCT05082961', 'acronym': 'CYRAD', 'briefTitle': 'Circulating Immunes Cells, Cytokines and Brain Radiotherapy', 'organization': {'class': 'OTHER', 'fullName': 'Centre Francois Baclesse'}, 'officialTitle': 'Circulating Immunes Cells, Cytokines and Brain Radiotherapy', 'orgStudyIdInfo': {'id': '2021-A01862-39'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'X-ray photon therapy + biological samples', 'interventionNames': ['Other: Collection of blood samples']}, {'type': 'OTHER', 'label': 'Protontherapy + biological samples', 'interventionNames': ['Other: Collection of blood samples']}], 'interventions': [{'name': 'Collection of blood samples', 'type': 'OTHER', 'description': 'Samples to evaluate the circulating CD8+ T cell count.', 'armGroupLabels': ['Protontherapy + biological samples', 'X-ray photon therapy + biological samples']}]}, 'contactsLocationsModule': {'locations': [{'zip': '14076', 'city': 'Caen', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Mathieu Cesaire, MD', 'role': 'CONTACT'}, {'name': 'Juliette Thariat, PhD', 'role': 'CONTACT'}, {'name': 'Carmen Florescu, MD', 'role': 'CONTACT'}, {'name': 'Julien Geffrelot, MD', 'role': 'CONTACT'}, {'name': 'Fernand Missohou, MD', 'role': 'CONTACT'}], 'facility': 'Centre François Baclesse', 'geoPoint': {'lat': 49.18585, 'lon': -0.35912}}], 'centralContacts': [{'name': 'Mathieu CESAIRE, MD', 'role': 'CONTACT', 'email': 'm.cesaire@baclesse.unicancer.fr', 'phone': '+33 (0)2 31 45 50 20'}, {'name': 'Jean-Michel GRELLARD', 'role': 'CONTACT', 'email': 'jm.grellard@baclesse.unicancer.fr', 'phone': '+33 (0)2 31 45 50 50'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Francois Baclesse', 'class': 'OTHER'}, 'collaborators': [{'name': 'Centre National de la Recherche Scientifique, France', 'class': 'OTHER'}, {'name': 'Ligue contre le cancer, France', 'class': 'OTHER'}, {'name': 'Fondation de France', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}