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| ID | Type | Description | Link |
|---|---|---|---|
| 2023-A00567-38 | Other Identifier | ANSM |
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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| circulating tumor DNA detection on operating bed | Experimental | biological assessment on operating bed to detect residual circulating tumor DNA |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Circulating tumor DNA detection | Other | biological assessment on operating bed to detect residual circulating tumor DNA |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lise-Marie Roussel, MD | Centre Henri Becquerel | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Rouen | Rouen | 76000 | France | |||
| Centre Henri Becquerel |
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| ID | Term |
|---|---|
| D000077195 | Squamous Cell Carcinoma of Head and Neck |
| D002294 | Carcinoma, Squamous Cell |
| ID | Term |
|---|---|
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| Rouen |
| 76038 |
| France |
| D006258 |
| Head and Neck Neoplasms |
| D009371 | Neoplasms by Site |
| D018307 | Neoplasms, Squamous Cell |