Cytological Screening for Early Diagnosis of Precancerous or Cancerous Lesions of Oral Cavity (Cytobuccale)

Toulouse University Hospital

Status: Completed

Conditions: Mouth Neoplasms

Treatments: Device: Orcellex® Rovers brush

Study type: Interventional

Funder types: Other

Identifiers

NCT02604121

12 045 03

Details and patient eligibility

About

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.

Enrollment: 200 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• one or several cancerous or pre-cancerous lesions of oral cavity newly diagnosed or detected during a follow-up visit

Exclusion criteria

• pregnant or lactating women
• patients under juridical protection

Trial design

Primary purpose: Screening

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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200 participants in 1 patient group

transepithelial brushing

Experimental group

Description:

transepithelial brushing in liquid-based technology + biopsy

Treatment:

Device: Orcellex® Rovers brush