Squamous Cell Carcinoma of the Oral Cavity
Conditions
Keywords
oral cavity, squamous cell carcinoma, residual tumor DNA, head and neck surgery
Brief summary
The aim of this study is to evaluate the interest of residual tumour DNA research in the operating bed after squamous cell carcinoma excision.
Detailed description
Squamous cell carcinomas of the oral cavity have a poor prognosis. The 5-year loco-regional recurrence rate is 45%. Surgery remains the standard treatment. The presence of invasive or insufficient surgical margins is an important histopronostic factor. Current tools for intraoperative detection of insufficient margins have a very low sensitivity of around 10%. The aim here is to develop a more sensitive tool by looking for the presence of residual tumour DNA in the entire operating bed after squamous cell carcinoma excision
Interventions
biological assessment on operating bed to detect residual circulating tumor DNA
Sponsors
Centre Henri Becquerel
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Signed informed consent * Patient with T1 to T4 squamous cell carcinoma of the oral cavity, regardless of lymph node status (all N) M0, operable * 18 years of age or older * Member or beneficiary of a social security scheme.
Exclusion criteria
* Absence of signed informed consent * Patient of protected age * Psychosocial problems * Not affiliated to or benefiting from a social security scheme * Previous cervical irradiation * Pregnant or breast-feeding women * Patient unable to understand the study for any reason or to comply with the constraints of the trial (language, psychological, geographical problems, etc.).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Residual tumro DNA on operating bed | during the surgery | Proportion of patients with residual tumour DNA on the operating bed according to the presence or absence of adverse histological factors |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Survival without locoregional recurrence rate | 24 months | Proportion of patients with circulating tumour DNA and in the cervical lymphatic drainage fluid or circulating blood according to the presence or absence of residual tumour DNA on the operating bed |
Countries
France
Outcome results
None listed