Clinical trial · Interventional

Study of the Role of Oncostatin M in Head and Neck Squamous Cell Carcinoma

NCT06199947CI-TRIAL-00072900unknownN/AClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

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.

Conditions

Conditions (2)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Cytokine	—	UNRESOLVED	—
Head and Neck Cancer	Malignant Head and Neck Neoplasm	ALIAS	0.90

Interventions

Interventions (1)

Intervention	Type	Mapped drug	Match
Biopsies and Blood collection	Other	—	UNRESOLVED

Design

Arms and outcomes

Arms (1)

type
EXPERIMENTAL
label
Samples
interventionNames
1. Other: Biopsies and Blood collection

Primary outcomes (1)

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
description
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.

Secondary outcomes (8)

measure

Eligibility

Eligibility (as posted)

Sex: All
Minimum age: 18 Years
Maximum age: 99 Years

Show eligibility criteria text

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

References

Publications (0)

Data not yet available

No reference posted for this study.