Contribution of Residual Tumour DNA Testing on the Surgical Bed

Study Overview
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Brief Summary
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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
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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

Official Title
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Contribution of Residual Tumour DNA Testing on the Surgical Bed of Squamous Cell Carcinomas of the Oral Cavity

Conditions
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Squamous Cell Carcinoma of the Oral Cavity

Intervention / Treatment
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* Other: Circulating tumor DNA detection


Participation Criteria
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Eligibility Criteria
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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.).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: circulating tumor DNA detection on operating bed<br>biological assessment on operating bed to detect residual circulating tumor DNA | Other: Circulating tumor DNA detection<br>* biological assessment on operating bed to detect residual circulating tumor DNA<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Residual tumro DNA on operating bed | Proportion of patients with residual tumour DNA on the operating bed according to the presence or absence of adverse histological factors | during the surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival without locoregional recurrence rate | 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 | 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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head and neck surgery, oral cavity, squamous cell carcinoma, residual tumor DNA