Clinical trial NCT06199947: Study of the Role of Oncostatin M in Head and Neck Squamous Cell Carcinoma
Official title: Study of the Role of Oncostatin M in Head and Neck Squamous Cell Carcinoma
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Head and Neck Cancer
Cytokine
Lead sponsor: Poitiers University Hospital
Sponsor class: OTHER
First posted: 2024-01-10
Enrollment: 119
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The ROMCOR study will be interested in the impact and the role of oncostatin M (OSM), a cytokine belonging to IL-6 superfamily, in the physiopathology of head and neck squamous cell carcinoma. The study team will study the impact of the presence of OSM and its main receptor OSM-R2 on several survival outcomes (overall survival, progression free survival) by multiple technics such as immunohistochemistry, transcriptomic in situ assays and spatial transcriptomic. Furthermore, the study team will try to show a link between serum level of several cytokines and in situ tumoral OSM.


Eligibility criteria: Inclusion Criteria:

* over 18 years of age;
* with suspected squamous cell carcinoma of the oral cavity, oropharynx or pharyngolarynx (any stage);
* with healthy, untreated contralateral mucosa and no contraindications to biopsy;
* with no history of any type of cancer;
* with a WHO performance status index of 0 to 2 inclusive ;
* able to receive treatment according to current European Society of Medical Oncology guidelines ;
* without guardianship, curatorship or subordination;
* benefiting from a Social Security scheme or benefiting from one through a third party;
* have given informed consent to participate in the study.

Exclusion Criteria:

* previously pre-treated in the ear, nose, throat sphere by radiotherapy or having already received anti-cancer chemotherapy;
* on long-term immunosuppressive therapy, defined as taking an immunosuppresseur, identified as such in the ATC classification, for 7 days, cortico-therapy \> 7.5mg/day for more than 3 months, treatment or history of anti-CD20 treatment within the year, or regular plasmatic exchange or gamma globulin infusion;
* benefiting from enhanced protection, i.e. minors, persons deprived of their liberty by a judicial or administrative decision, persons staying in a health or social establishment, adults under legal protection;
* pregnant or breast-feeding women of childbearing age (menopause must be documented and more than 2 years old) who refuse or do not have an effective method of contraception (hormonal/mechanical: oral, injectable, transcutaneous, implantable, intrauterine device, or surgical: tubal ligation, hysterectomy, total oophorectomy) for the duration of the study.
* final diagnosis of non-squamous cell carcinoma

Primary outcomes:
measure: To analyze the relative expression of OSM, several inflammatory cytokines and their receptors in head and neck squamous cell carcinomas (SCC).
timeFrame: 1 month
Secondary outcomes:
measure: Analysis of the tumor immune cell microenvironment that secret OSM in head and neck squamous cell carcinoma with the cell-selectine RNA sequencing method.
timeFrame: 1 month
measure: Relative expression by RT-qPCR of epithelial-mesenchymal transition (EMT) transcripts will be compared in tumoral mucosa versus normal mucosa of patients
timeFrame: 1 month
measure: Correlation between relative expression of OSM and OSM-R by RT-qPCR and the relative expression of epithelial-mesenchymal transition transcripts in tumoral mucosa
timeFrame: 1 month
measure: Caracterisation of the prognostic impact of tissue-level immunohistochemistry expression of OSM and OSM-R at diagnosis on progression-free survival.
timeFrame: 18 month
measure: Caracterisation of the prognostic impact of transcriptomic expression of OSM and OSM-R at diagnosis on progression-free survival.
timeFrame: 18 month
measure: Correlation between serum concentrations of OSM and several circulating inflammatory cytokines and their respective expression in tumor tissue in head and neck squamous cell carcinoma at diagnosis.
timeFrame: 1 month
measure: Caracterisation of the prognostic impact of serum OSM concentrations at diagnosis on progression-free survival
timeFrame: 1 month
measure: Caracterisation of the relationship between changes in serum cytokine concentrations (between the time of diagnosis and 3 months after the end of initial treatment) and early response to treatment (3 months after the end of initial treatment).
timeFrame: 18 month
Other outcomes:
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