Contribution of Residual Tumour DNA Testing on the Surgical Bed
- Conditions
- Squamous Cell Carcinoma of the Oral Cavity
- Interventions
- Other: Circulating tumor DNA detection
- Registration Number
- NCT05934929
- Lead Sponsor
- Centre Henri Becquerel
- 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
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 26
- 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.
- 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.).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description circulating tumor DNA detection on operating bed Circulating tumor DNA detection biological assessment on operating bed to detect residual circulating tumor DNA
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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
Trial Locations
- Locations (2)
CHU Rouen
🇫🇷Rouen, France
Centre Henri Becquerel
🇫🇷Rouen, France