Contribution of Residual Tumour DNA Testing on the Surgical Bed

Squamous Cell Carcinoma of the Oral Cavity Clinical Trial

— MARGINS  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05934929
• Other study ID #: CHB23.01
• Secondary ID: 2023-A00567-38
• Status: Not yet recruiting
• Phase: N/A
• Start date: August 1, 2023
• Est. completion date: August 1, 2027

Study information

• Verified date: June 2023
• Source: Centre Henri Becquerel
• Contact: Lise-Marie Roussel, MD
• Phone: +33232082985
• Email: lise-marie.roussel[@]chb.unicancer.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Not yet recruiting
• Enrollment: 26
• Est. completion date: August 1, 2027
• Est. primary completion date: February 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.).

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Squamous Cell
• Neoplasm, Residual
• Squamous Cell Carcinoma of the Oral Cavity

Intervention

Other:
• Circulating tumor DNA detection
biological assessment on operating bed to detect residual circulating tumor DNA

Locations

Country	Name	City	State
France	Centre Henri Becquerel	Rouen
France	CHU Rouen	Rouen

Sponsors (1)

Lead Sponsor	Collaborator
Centre Henri Becquerel

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	during the surgery
Secondary	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	24 months