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

Mouth Neoplasms Clinical Trial

— Cytobuccale  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02604121
• Other study ID #: 12 045 03
• Status: Completed
• Phase: N/A
• Start date: February 2013
• Est. completion date: February 2019

Study information

• Verified date: April 2019
• Source: University Hospital, Toulouse
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: February 2019
• Est. primary completion date: February 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Mouth Neoplasms

Intervention

Device:
• Orcellex® Rovers brush
transepithelial brushing

Locations

Country	Name	City	State
France	University Hospital Toulouse	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Toulouse

Country where clinical trial is conducted

France, 

Outcome

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