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

Interest of Cytological Screening for Early Diagnosis of Precancerous or Cancerous Lesions of Oral Cavity by Transepithelial Brushing in Liquid-based

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02604121

Acronym

Cytobuccale

Enrollment

200

Registered

2015-11-13

Start date

2013-02-28

Completion date

2019-02-28

Last updated

2019-04-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mouth Neoplasms

Keywords

oral cavity, cancerous and precancerous lesions

Brief summary

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.

Interventions

DEVICEOrcellex® Rovers brush

transepithelial brushing

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

SCREENING

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

20 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
Diagnostic validity of lesion (Bethesda system, 2001)	baseline	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

Secondary

Measure	Time frame	Description
Diagnostic validity - predictive value (positive and negative)	baseline	Calculation of predictive value (positive and negative) of cytology / the reference is histology of biopsy
Feasibility of cytology	Baseline	sample rate not satisfactory= hemorrhage hiding the cells of interest
Reproducibility intra and inter observers (coefficient of kappa de cohen)	Baseline	reproducibility intra and inter observers of cytology interpretation (kappa de cohen)

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026