Contribution of Residual Tumour DNA Testing on the Surgical Bed (MARGINS)

Centre Henri Becquerel

Status

Active, not recruiting

Conditions

Squamous Cell Carcinoma of the Oral Cavity

Treatments

Other: Circulating tumor DNA detection

Study type

Interventional

Funder types

Other

Identifiers

NCT05934929

2023-A00567-38 (Other Identifier)

CHB23.01

Details and patient eligibility

About

The aim of this study is to evaluate the interest of residual tumour DNA research in the operating bed after squamous cell carcinoma excision.

Full 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

Enrollment

31 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.).