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Completed

NCT Number: NCT01167790

Autofluorescence for the Screening of Precancerous and Malignant Lesions

Diagnosis of oral squamous cell carcinoma is always too late. Due to this delay for diagnosis, prognosis is very bad. It has been demonstrate that systematic oral examination decrease mortality in tobacco and alcohol consumers population (Sankaranarayanan and al. Lancet 2005, 4, 1927-1933 ). An other study has demonstrate that autofluorescence is a useful technic for detection of dysplasia and squamous cell carcinoma that cannot be seen with conventional oral examination((Poh CF Wink Cancer Res on 2006 ( 22 ): 6616-22; Poh CF Head Neck 2007 ( 1 ) 7 71-6).However autofluorescence has never been evaluated has a screening tool for systematic oral examination and the reproductibility has never been studied.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hopital Saint André

Bordeaux, 33000, France

About this study

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 disorders.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 patient

Treatment and study plan

buccal cavity examination

Procedure

autofluorescence examination

Primary outcomes

  1. reliability

    Time frame: one day

    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)

Secondary outcomes

  1. Prevalence

    Time frame: one day

    Prevalence of potentially malignant lesions, dysplasia and cancer patient of the oral cavity in conditions of screening in an alcoolo-smoking population.

  2. Validity

    Time frame: one day

    anatomopathologic diagnosis wil be compared to examination in both techniques of examination

  3. safety

    Time frame: one day

    adverse events of the procedure (biopsy)

Sponsors and collaborators

Lead sponsor

University Hospital, Bordeaux

Other

Registry information

Official study title

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

Acronym: FLUOK

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Jul 22, 2010
Registry last updated
May 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.