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

Not Applicable

Completed

• Conditions: Mouth Neoplasms
• Interventions: Device: Orcellex® Rovers brush

• Registration Number: NCT02604121
• Lead Sponsor: University Hospital, Toulouse

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-02
• Study First Submitted: 2015-08-18
• Study First Submitted QC: 2015-11-12
• Study First Posted: 2015-11-13
• Primary Completion: 2019-02
• Study Completion: 2019-02
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-16
• Last Update Posted: 2019-04-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
transepithelial brushing	Orcellex® Rovers brush	transepithelial brushing in liquid-based technology + biopsy

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Reproducibility intra and inter observers (coefficient of kappa de cohen)	Baseline	reproducibility intra and inter observers of cytology interpretation (kappa de cohen)
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 : low cellularity of the material

Trial Locations

Locations (1)

University Hospital Toulouse; 🇫🇷 Toulouse, France