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

Primary Purpose

Mouth Neoplasms

Status

Completed

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

Orcellex® Rovers brush

About this trial

This is an interventional screening trial for Mouth Neoplasms focused on measuring oral cavity, cancerous and precancerous lesions

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

University Hospital Toulouse

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

transepithelial brushing

Arm Description

transepithelial brushing in liquid-based technology + biopsy

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Diagnostic validity - predictive value (positive and negative)

Calculation of predictive value (positive and negative) of cytology / the reference is histology of biopsy

Feasibility of cytology

sample rate not satisfactory= hemorrhage hiding the cells of interest

Feasibility of cytology

sample rate not satisfactory : low cellularity of the material

Reproducibility intra and inter observers (coefficient of kappa de cohen)

reproducibility intra and inter observers of cytology interpretation (kappa de cohen)

Full Information

NCT ID

NCT02604121

First Posted

August 18, 2015

Last Updated

April 16, 2019

Sponsor

University Hospital, Toulouse

1. Study Identification

Unique Protocol Identification Number

NCT02604121

Brief Title

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

Acronym

Cytobuccale

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2019

Overall Recruitment Status

Completed

Study Start Date

February 2013 (Actual)

Primary Completion Date

February 2019 (Actual)

Study Completion Date

February 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University Hospital, Toulouse

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Mouth Neoplasms

Keywords

oral cavity, cancerous and precancerous lesions

7. Study Design

Primary Purpose

Screening

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

200 (Actual)

8. Arms, Groups, and Interventions

Arm Title

transepithelial brushing

Arm Type

Experimental

Arm Description

transepithelial brushing in liquid-based technology + biopsy

Intervention Type

Device

Intervention Name(s)

Orcellex® Rovers brush

Intervention Description

transepithelial brushing

Primary Outcome Measure Information:

Title

Diagnostic validity of lesion (Bethesda system, 2001)

Description

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

Secondary Outcome Measure Information:

Title

Diagnostic validity - predictive value (positive and negative)

Description

Calculation of predictive value (positive and negative) of cytology / the reference is histology of biopsy

Time Frame

baseline

Title

Feasibility of cytology

Description

sample rate not satisfactory= hemorrhage hiding the cells of interest

Time Frame

Baseline

Title

Feasibility of cytology

Description

sample rate not satisfactory : low cellularity of the material

Time Frame

Baseline

Title

Reproducibility intra and inter observers (coefficient of kappa de cohen)

Description

reproducibility intra and inter observers of cytology interpretation (kappa de cohen)

Time Frame

Baseline

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Laetitia COLIN-LACOSTE, MD

Organizational Affiliation

University Hospital, Toulouse

Official's Role

Principal Investigator

Facility Information:

Facility Name

University Hospital Toulouse

City

Toulouse

ZIP/Postal Code

31059

Country

France

12. IPD Sharing Statement

Learn more about this trial

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

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