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

NCT ID: NCT06199947

Last Updated: 2024-01-10

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 119 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-02-29
• Study Completion Date: 2025-12-31

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 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

Head and Neck Cancer; Cytokine

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Samples

Group Type: EXPERIMENTAL

Biopsies and Blood collection

Intervention Type: OTHER

Each participant will have 2 additionnal biopsies during his/her diagnostic endoscopy plus two blood test during his/her inclusion

Interventions

Biopsies and Blood collection

Each participant will have 2 additionnal biopsies during his/her diagnostic endoscopy plus two blood test during his/her inclusion

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Poitiers University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

BAINAUD MATTHIEU, Dr

Role: CONTACT

matthieu.bainaud@gmail.com

+33549444125

Other Identifiers

ROMCOR

Identifier Type: -

Identifier Source: org_study_id