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

April 16, 2019 updated by: University Hospital, Toulouse

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Toulouse, France, 31059
        • University Hospital Toulouse

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: transepithelial brushing
transepithelial brushing in liquid-based technology + biopsy
Device: Orcellex® Rovers brush
transepithelial brushing

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diagnostic validity of lesion (Bethesda system, 2001)
Time Frame: 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
baseline

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Toulouse

Investigators

  • Principal Investigator: Laetitia COLIN-LACOSTE, MD, University Hospital, Toulouse

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2013

Primary Completion (Actual)

February 1, 2019

Study Completion (Actual)

February 1, 2019

Study Registration Dates

First Submitted

August 18, 2015

First Submitted That Met QC Criteria

November 12, 2015

First Posted (Estimate)

November 13, 2015

Study Record Updates

Last Update Posted (Actual)

April 17, 2019

Last Update Submitted That Met QC Criteria

April 16, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 12 045 03

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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