Contribution of Residual Tumour DNA Testing on the Surgical Bed

N/AActive Not RecruitingNCT05934929

Centre Henri Becquerel31 enrolled

Overview

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

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

Study Type

INTERVENTIONAL

Allocation

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Squamous Cell Carcinoma of the Oral Cavity

Interventions

Circulating tumor DNA detectionOTHER

biological assessment on operating bed to detect residual circulating tumor DNA

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.).

Locations (2)

CHU Rouen

Rouen, France

Centre Henri Becquerel

Rouen, France

Outcomes

Primary Outcomes

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

Time frame: during the surgery

Secondary Outcomes

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

Time frame: 24 months

Data from ClinicalTrials.gov

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