Study of the Role of Oncostatin M in Head and Neck Squamous Cell Carcinoma
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 119
- 主要终点
- To analyze the relative expression of OSM, several inflammatory cytokines and their receptors in head and neck squamous cell carcinomas (SCC).
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
结局指标
主要结局
To analyze the relative expression of OSM, several inflammatory cytokines and their receptors in head and neck squamous cell carcinomas (SCC).
时间窗: 1 month
The relative expression of transcripts for OSM, OSM-R, as well as the main inflammatory cytokines and their receptors (LIFR, Gp130, IL-31, IL6, IL-1β, TNF-α, IL-4, IL-10, IL-34, CXCL8, CXCL2, IL-17 and GCSF) will be compared between tumor and non-tumor biopsy samples. These comparisons will also be stratified by disease stage (localized, locally advanced, metastatic). Cytokine expression will be studied by RT-qPCR after RNA extraction and retro-transcription on frozen tissue biopsies (tumor and non-tumor) in nitrogen, and the value will be expressed in relation to the expression of two common housekeeping genes, GADPH and Actin B.
次要结局
- Analysis of the tumor immune cell microenvironment that secret OSM in head and neck squamous cell carcinoma with the cell-selectine RNA sequencing method.(1 month)
- Caracterisation of the prognostic impact of tissue-level immunohistochemistry expression of OSM and OSM-R at diagnosis on progression-free survival.(18 month)
- 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.(1 month)
- 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).(18 month)
- Correlation between relative expression of OSM and OSM-R by RT-qPCR and the relative expression of epithelial-mesenchymal transition transcripts in tumoral mucosa(1 month)
- Relative expression by RT-qPCR of epithelial-mesenchymal transition (EMT) transcripts will be compared in tumoral mucosa versus normal mucosa of patients(1 month)
- Caracterisation of the prognostic impact of serum OSM concentrations at diagnosis on progression-free survival(1 month)
- Caracterisation of the prognostic impact of transcriptomic expression of OSM and OSM-R at diagnosis on progression-free survival.(18 month)