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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Samples | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Biopsies and Blood collection | Other | Each participant will have 2 additionnal biopsies during his/her diagnostic endoscopy plus two blood test during his/her inclusion |
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| Measure | Description | Time Frame |
|---|---|---|
| To analyze the relative expression of OSM, several inflammatory cytokines and their receptors in head and neck squamous cell carcinomas (SCC). | 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. | 1 month |
| Measure | Description | Time Frame |
|---|---|---|
| Analysis of the tumor immune cell microenvironment that secret OSM in head and neck squamous cell carcinoma with the cell-selectine RNA sequencing method. | To know what type of cells secrete OSM in the microenvironment, we will use GeoMx Nanostring (c) technique. It consists of a selective RNA or protein sequecing of immunofluorescence labelled cells on parrafine embedded tissues. Investigators will then label OSM-secreting cells with anti-OSM fluorochrome and collect it to be sequenced |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| BAINAUD MATTHIEU, Dr | Contact | +33549444125 | matthieu.bainaud@gmail.com |
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| ID | Term |
|---|---|
| D006258 | Head and Neck Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D001706 | Biopsy |
| ID | Term |
|---|---|
| D003581 | Cytodiagnosis |
| D003584 | Cytological Techniques |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
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| 1 month |
| Relative expression by RT-qPCR of epithelial-mesenchymal transition (EMT) transcripts will be compared in tumoral mucosa versus normal mucosa of patients | Investigators will study the following genes : SNAI1, SERPIN B3, TGM2, ZEB1, YAP-1, FAT-1, CK13, VIM, OCT-4, SOX-2, CD-44, BMI-1 and KLF-4 | 1 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 | Investigators will study the following genes : SNAI1, SERPIN B3, TGM2, ZEB1, YAP-1, FAT-1, CK13, VIM, OCT-4, SOX-2, CD-44, BMI-1 and KLF-4 | 1 month |
| Caracterisation of the prognostic impact of tissue-level immunohistochemistry expression of OSM and OSM-R at diagnosis on progression-free survival. | Tissues will be classified as OSM positive (positive staining) or negative (no staining) and OSM-R positive or negative. Progression-free survival of positive and negative patients will be compared. PFS will be defined as a composite criterion :progression of the mesurable target > 20%, progression > 20% AND at least 5mm and emergence of new lesions PFS will be mesured at 12 and 18 months | 18 month |
| Caracterisation of the prognostic impact of transcriptomic expression of OSM and OSM-R at diagnosis on progression-free survival. | Biopsies will be classified as OSM / OSM-R overexpressing tissue (ratio : relative expression of OSM and OSM-R in tumoral mucosa / relative expression of OSM and OSM-R in normal mucosa by RT-qPCR is above the median) or underexpressing tissue (ratio under the median). Progression-free survival of overexpressing and underexpressing patients will be compared. PFS will be defined as a composite criterion :progression of the mesurable target > 20%, progression > 20% AND at least 5mm and emergence of new lesions PFS will be mesured at 12 and 18 months | 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. | OSM and other cytokines (LIFR, le Gp130, l'IL-31, l'IL6, l'IL-1β, le TNF-α, l'IL-4, l'IL-10, l'IL-34, le CXCL8, le CXCL2, l'IL-17 et le GCSF) will be analysed by the semi-quantitative ELISA technique on patients's sera. Same cytokines will be assessed in tumoral mucosa by RT-qPCR. Comparison between their relative expression by RT-qPCR and their serum concentration will be study | 1 month |
| Caracterisation of the prognostic impact of serum OSM concentrations at diagnosis on progression-free survival | Patients will be classified as high serum concentration of OSM at baseline or low serum concentration at baseline (concentration cut-off not known in literature) using the semi-quantitative ELISA technique. Progression-free survival of overexpressing and underexpressing patients will be compared. PFS will be defined as a composite criterion :progression of the mesurable target > 20%, progression > 20% AND at least 5mm and emergence of new lesions PFS will be mesured at 12 and 18 months | 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). | For each cytokines dosed in serum, we will describe if the variation of their concentrations (R= T0 - (T0+Dt/T0))*100 ) as an impact on the response at 3 month (defined as the V2 visit). Reponse rate is defined as (RECIST v1.1) : complete response : no residual disease is clinically or radiologically assessable at 3 month partial response : decrease of the mesurable targets of more than 30% but still assessable stable disease : modification of the mesurable targets between a decrease of less than 30% and a progression of less than 20% progression : progression of the mesurable targets of more than 20% | 18 month |
| D003933 | Diagnosis |
| D013048 | Specimen Handling |
| D003949 | Diagnostic Techniques, Surgical |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |