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Prospective study of diagnosis validation of a cytological technique. 200 patients with oral cavity cancerous and precancerous lesions will be enrolled.
A cytological sample of the lesion will be performed by transepithelial brushing ( Orcellex® Rovers brush) in cytology liquid-based technology (methode ThinPrep 2000 (Hologic®)). A microscopic double blind reading will be performed. A biopsy sampling will be carried out in accordance with current strategy of screening. The brushing diagnosis quality will be compared to the biopsy which is the gold standard.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| transepithelial brushing | Experimental | transepithelial brushing in liquid-based technology + biopsy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Orcellex® Rovers brush | Device | transepithelial brushing |
|
| Measure | Description | Time Frame |
|---|---|---|
| Diagnostic validity of lesion (Bethesda system, 2001) | Diagnostic validity (specificity and sensibility, the classification of lesions is performed according Bethesda system, 2001 and the reference is the histology of biopsy of lesion | baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Diagnostic validity - predictive value (positive and negative) | Calculation of predictive value (positive and negative) of cytology / the reference is histology of biopsy | baseline |
| Feasibility of cytology |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Laetitia COLIN-LACOSTE, MD | University Hospital, Toulouse | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Toulouse | Toulouse | 31059 | France |
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| ID | Term |
|---|---|
| D009062 | Mouth Neoplasms |
| ID | Term |
|---|---|
| D006258 | Head and Neck Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D009059 | Mouth Diseases |
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sample rate not satisfactory= hemorrhage hiding the cells of interest
| Baseline |
| Feasibility of cytology | sample rate not satisfactory : low cellularity of the material | Baseline |
| Reproducibility intra and inter observers (coefficient of kappa de cohen) | reproducibility intra and inter observers of cytology interpretation (kappa de cohen) | Baseline |
| D009057 |
| Stomatognathic Diseases |