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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
SCREENING
Masking
NONE
Enrollment
200
transepithelial brushing
University Hospital Toulouse
Toulouse, France
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
Time frame: baseline
Diagnostic validity - predictive value (positive and negative)
Calculation of predictive value (positive and negative) of cytology / the reference is histology of biopsy
Time frame: baseline
Feasibility of cytology
sample rate not satisfactory= hemorrhage hiding the cells of interest
Time frame: Baseline
Feasibility of cytology
sample rate not satisfactory : low cellularity of the material
Time frame: Baseline
Reproducibility intra and inter observers (coefficient of kappa de cohen)
reproducibility intra and inter observers of cytology interpretation (kappa de cohen)
Time frame: Baseline
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.