Circulating Immunes Cells, Cytokines and Brain Radiotherapy
NCT ID: NCT05082961
Last Updated: 2024-12-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
40 participants
INTERVENTIONAL
2022-01-27
2028-10-31
Brief Summary
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In 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.
Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
OTHER
SINGLE
Study Groups
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X-ray photon therapy + biological samples
Collection of blood samples
Samples to evaluate the circulating CD8+ T cell count.
Protontherapy + biological samples
Collection of blood samples
Samples to evaluate the circulating CD8+ T cell count.
Interventions
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Collection of blood samples
Samples to evaluate the circulating CD8+ T cell count.
Eligibility Criteria
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Inclusion Criteria
* Head and neck cancer: (upper aerodigestive tract, cavum, facial sinus, skull base, brain) operated
* Surgery for complete tumour resection or with microscopic residue R1
* All possible histologies: squamous cell carcinoma, undifferentiated carcinoma of the nasopharyngeal type (UCNT), adenocarcinoma, adenoid cystic carcinoma, chordoma, chondrosarcoma,meningioma other tumours
* Patients undergoing exclusive postoperative radiotherapy with a minimum total dose of 54 Gy of X-ray photon radiation or equivalent proton radiation.
* Patient affiliated to a social security scheme
* Signature of the informed consent before any specific procedure related to the study
Exclusion Criteria
* Previous cancer within 5 years (except treated basal cell skin carcinoma and treated cervical cancer).
* Previous radiotherapy (except brachytherapy of the cervix or prostate)
* Chemotherapy or other systemic oncological treatment (cetuximab) concomitant with radiotherapy
* Long-term immunosuppressive or corticosteroid therapy
* Patient deprived of liberty or under guardianship, protected adult
* Patient unable to undergo trial monitoring for geographical, social or psychopathological reasons
* Pregnant or breastfeeding woman
* Emergency situations
18 Years
ALL
No
Sponsors
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Centre National de la Recherche Scientifique, France
OTHER
Ligue contre le cancer, France
OTHER
Fondation de France
OTHER
Centre Francois Baclesse
OTHER
Responsible Party
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Locations
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Centre François Baclesse
Caen, , France
Countries
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Central Contacts
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Facility Contacts
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Mathieu Cesaire, MD
Role: primary
Juliette Thariat, PhD
Role: backup
Carmen Florescu, MD
Role: backup
Julien Geffrelot, MD
Role: backup
Fernand Missohou, MD
Role: backup
References
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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.
Other Identifiers
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2021-A01862-39
Identifier Type: -
Identifier Source: org_study_id