Head and Neck CancerCYRADNCT05082961
Circulating Immunes Cells, Cytokines and Brain Radiotherapy
A study testing Collection of blood samples in people with Head and Neck Cancer, run by Centre Francois Baclesse at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Cancer
- What is being tested?
- Collection of blood samples
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- 27 Jan 2022to Oct 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients > 18 years
- 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
Who cannot join
- Macroscopic postoperative tumour residue R2
- 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
Show all 9Show fewer
- Patient unable to undergo trial monitoring for geographical, social or psychopathological reasons
- Pregnant or breastfeeding woman
- Emergency situations
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Centre François Baclesse
Caen, 14076
Mathieu Cesaire, MD
Juliette Thariat, PhD
About this study
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.
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.
- Conditions
- Head and Neck Cancer
- Being tested
- Collection of blood samples
- Medical subject headings
- Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Collection of blood samplesOther
Samples to evaluate the circulating CD8+ T cell count.
| Study group | Role | What they receive |
|---|---|---|
| X-ray photon therapy + biological samples | Other | Not described Receives: Other: Collection of blood samples |
| Protontherapy + biological samples | Other | Not described Receives: Other: Collection of blood samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
CD8+ T-cell count.
Measured: up to 3 months
Secondary outcomes (2)
CD4+ Lymphocytes T count
Measured: up to 3 months
Regulatory T cells
Measured: up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2021
- Study start27 Jan 2022
- Primary completionApr 2028 (estimated)
- Study completionOct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Head and Neck CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Francois Baclesse
- Sponsor type
- University, hospital or other
- Collaborators
- Centre National de la Recherche Scientifique, France, Ligue contre le cancer, France, Fondation de France
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05082961
- Sponsor's protocol ID
- 2021-A01862-39
- Acronym
- CYRAD
- Status last verified
- Dec 2024
- First submitted
- 6 Oct 2021
- Last updated
- 11 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 39369231
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Circulating Immunes Cells, Cytokines and Brain Radiotherapy
- ClinicalTrials.gov ID
- NCT05082961
- Acronym / sponsor ID
- CYRAD / 2021-A01862-39
- Conditions
- Head and Neck Cancer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Centre Francois BaclesseUniversity, hospital or other
- Collaborators
- Centre National de la Recherche Scientifique, France, Ligue contre le cancer, France, Fondation de France
- Study start
- 27 Jan 2022 (actual)
- Primary completion
- Apr 2028 (estimated)
- Study completion
- Oct 2028 (estimated)
- First posted
- 19 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| X-ray photon therapy + biological samples | Other | Other: Collection of blood samples |
| Protontherapy + biological samples | Other | Other: Collection of blood samples |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients > 18 years
- 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.
Key exclusion criteria (9 listed)
- Macroscopic postoperative tumour residue R2
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Collection of blood samplesSamples to evaluate the circulating CD8+ T cell count. | Other | Protontherapy + biological samples, X-ray photon therapy + biological samples |
Primary outcome
CD8+ T-cell count.
Time frame: up to 3 months
2 secondary outcomes
CD4+ Lymphocytes T count
Time frame: up to 3 months
Regulatory T cells
Time frame: up to 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2024.
- Derived from this study: PubMed 39369231Thariat 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Collection of blood samples in people with Head and Neck Cancer, run by Centre Francois Baclesse at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mathieu CESAIRE, MD (+33 (0)2 31 45 50 20, m.cesaire@baclesse.unicancer.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CD8+ T-cell count. (time frame: up to 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05082961, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2024.