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

P

Poitiers University Hospital

Status

Not yet enrolling

Conditions

Cytokine
Head and Neck Cancer

Treatments

Other: Biopsies and Blood collection

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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.

Enrollment

119 estimated patients

Sex

All

Ages

18 to 99 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Basic Science

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

119 participants in 1 patient group

Samples
Experimental group
Treatment:
Other: Biopsies and Blood collection

Trial contacts and locations

0

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Central trial contact

BAINAUD MATTHIEU, Dr

Data sourced from clinicaltrials.gov

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