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Trial Title:
Contribution of Residual Tumour DNA Testing on the Surgical Bed
NCT ID:
NCT05934929
Condition:
Squamous Cell Carcinoma of the Oral Cavity
Conditions: Official terms:
Carcinoma
Carcinoma, Squamous Cell
Neoplasm, Residual
Conditions: Keywords:
oral cavity
squamous cell carcinoma
residual tumor DNA
head and neck surgery
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Other
Masking:
None (Open Label)
Intervention:
Intervention type:
Other
Intervention name:
Circulating tumor DNA detection
Description:
biological assessment on operating bed to detect residual circulating tumor DNA
Arm group label:
circulating tumor DNA detection on operating bed
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.
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
Criteria for eligibility:
Criteria:
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.).
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
CHU Rouen
Address:
City:
Rouen
Zip:
76000
Country:
France
Contact:
Last name:
Sophie Deneuve, Md
Email:
sophie.deneuve@chu-rouen.fr
Investigator:
Last name:
Sophie Deneuve, Md
Email:
Principal Investigator
Facility:
Name:
Centre Henri Becquerel
Address:
City:
Rouen
Zip:
76038
Country:
France
Contact:
Last name:
Lise-Marie Roussel, MD
Phone:
+33232082985
Email:
lise-marie.roussel@chb.unicancer.fr
Investigator:
Last name:
Lise-Marie Roussel, Md
Email:
Principal Investigator
Start date:
August 1, 2023
Completion date:
August 1, 2027
Lead sponsor:
Agency:
Centre Henri Becquerel
Agency class:
Other
Source:
Centre Henri Becquerel
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05934929
