Status:
NOT_YET_RECRUITING
Study of the Role of Oncostatin M in Head and Neck Squamous Cell Carcinoma
Lead Sponsor:
Poitiers University Hospital
Conditions:
Head and Neck Cancer
Cytokine
Eligibility:
All Genders
18-99 years
Phase:
NA
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 stu...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
119 Patients enrolled
Trial Details
Trial ID
NCT06199947
Start Date
February 1 2024
End Date
December 1 2025
Last Update
January 10 2024
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