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Interest of Oral Tissue Autofluorescence for the Screening of Precancerous Lesions and Cancer in Population With Tobacco and Alcohol Abuse.

18 Years
Not Enrolling
Precancerous Lesions of the Oral Mucosa

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Trial Information

Interest of Oral Tissue Autofluorescence for the Screening of Precancerous Lesions and Cancer in Population With Tobacco and Alcohol Abuse.

The study of Sankaranarayanan and al. (Lancet on 2005, 4, 1927-1933) demonstrated the
influence on the decline of mortality of a realized systematic screening, by a simple visual
inspection of the oral cavity in alcohol-smoker patients. The sensibility of the visual
inspection to diagnose the oral cancers is estimated at 85 % and the specificity in 97 %.
However some lésions are not diagnosed with common oral examination(Downer MC Oral Oncol.
2004 ( 3 ) 264-73). The examination in autofluorescence coupled with the visual inspection
could be a solution to improve early diagnosis of potentially malignant disorders . Indeed,
dysplasia and cancerous lesions can be revealing by an autofluorescence examination (Lane
PM J Biomed opt on 2006 ( 2 ): 024006). Other works demonstrated that infra-clinical lesions
could be revealed by the autofluorescence (Poh CF Wink Cancer Res on 2006 ( 22 ): 6616-22;
Poh CF Head Neck 2007 ( 1 ) 7 71-6). On the other hand the sensibility and the specificity
of the autofluorescence in situation of screening were not estimated and studies carried out
on sick subjects tend to overestimate the metrological performances of a technique. Besides
the reliability of the technique (reproducibility) was not studied. For these reasons, it is
recommended to realize in situation of screening in an alcohol-smoker population:

- a study of reliability to estimate the reproducibility inter-observer of the
examination of the oral cavity in tissular autofluorescence and,

- a feasibility study to estimate the potential contribution of the autofluorescence with
regard to a simple visual inspection in the screening of the potential malignant

Inclusion Criteria:

- patients hospitalized for alcoholic weaning

- consumption activates of tobacco or stop for less than one year

- consent form signed

Exclusion Criteria:

- patient presenting a disorder of the haemostasis (plaques < 50G / L; INR > 3,
haemophilia, moderate or severe Willebrand disease),

- absorption of acid acetylsalicylic in seven days before inclusion,

- the patient with oral cavity precancerous pathology, dysplasia or known cancer

Type of Study:


Study Design:

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:


Outcome Description:

Concordance inter-observer, considered by the coefficient kappa of Cohen, towards the decision to make a biopsy of a suspicious lesion(potentially malignant lesions, dysplasia and cancer)

Outcome Time Frame:

one day

Safety Issue:


Principal Investigator

Jean-chritophe FRICAIN, Md-PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University Hospital, Bordeaux


France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:

CHUBX 2010/02



Start Date:

July 2010

Completion Date:

March 2012

Related Keywords:

  • Precancerous Lesions of the Oral Mucosa
  • Precancerous lesions of the oral mucosa
  • Fluorescence visualization