Contribution of Residual Tumour DNA Testing on the Surgical Bed

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Squamous Cell Carcinoma of the Oral Cavity Carcinoma Carcinoma, Squamous Cell Head and Neck Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Neoplasms, Squamous Cell Squamous Cell Carcinoma of Head and Neck

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU Rouen, Rouen, France

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.).

Treatment and study plan

circulating tumor DNA detection

Other

biological assessment on operating bed to detect residual circulating tumor DNA

Primary outcomes

Residual tumro DNA on operating bed

Time frame: 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 outcomes

Survival without locoregional recurrence rate

Time frame: 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

Sponsors and collaborators

Lead sponsor

Centre Henri Becquerel

Other

Registry information

Official study title

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

Acronym: MARGINS

Important dates

Study start: 2024
Primary completion: 2025
Study completion: 2027
First posted: Jul 7, 2023
Registry last updated: Jan 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed