MARGINS: Contribution of Residual Tumour DNA Testing on the Surgical Bed

Sponsor

Centre Henri Becquerel (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05934929

Collaborator

(none)

Enrollment

Locations

Arm

Anticipated Duration (Months)

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Squamous Cell Carcinoma of the Oral Cavity	Other: Circulating tumor DNA detection	N/A

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

Study Design

Study Type:

Interventional

Anticipated Enrollment :

26 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

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

Anticipated Study Start Date :

Aug 1, 2023

Anticipated Primary Completion Date :

Feb 1, 2025

Anticipated Study Completion Date :

Aug 1, 2027

Arms and Interventions

Arm	Intervention/Treatment
Experimental: circulating tumor DNA detection on operating bed biological assessment on operating bed to detect residual circulating tumor DNA	Other: Circulating tumor DNA detection biological assessment on operating bed to detect residual circulating tumor DNA

Arm

Intervention/Treatment

Experimental: circulating tumor DNA detection on operating bed

biological assessment on operating bed to detect residual circulating tumor DNA

Other: Circulating tumor DNA detection

biological assessment on operating bed to detect residual circulating tumor DNA

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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.).