Autofluorescence for the Screening of Precancerous and Malignant Lesions (FLUOK)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University Hospital, Bordeaux
ClinicalTrials.gov Identifier:
NCT01167790
First received: July 21, 2010
Last updated: June 13, 2012
Last verified: June 2012
  Purpose

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.


Condition Intervention
Precancerous Lesions of the Oral Mucosa
Procedure: buccal cavity examination

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Interest of Oral Tissue Autofluorescence for the Screening of Precancerous Lesions and Cancer in Population With Tobacco and Alcohol Abuse.

Resource links provided by NLM:


Further study details as provided by University Hospital, Bordeaux:

Primary Outcome Measures:
  • reliability [ Time Frame: one day ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • Prevalence [ Time Frame: one day ] [ Designated as safety issue: No ]
    Prevalence of potentially malignant lesions, dysplasia and cancer patient of the oral cavity in conditions of screening in an alcoolo-smoking population.

  • Validity [ Time Frame: one day ] [ Designated as safety issue: No ]
    anatomopathologic diagnosis wil be compared to examination in both techniques of examination

  • safety [ Time Frame: one day ] [ Designated as safety issue: Yes ]
    adverse events of the procedure (biopsy)


Enrollment: 180
Study Start Date: July 2010
Study Completion Date: March 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    Procedure: buccal cavity examination
    autofluorescence examination
Detailed Description:

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.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01167790

Locations
France
Hopital Saint André
Bordeaux, France, 33000
Sponsors and Collaborators
University Hospital, Bordeaux
Investigators
Principal Investigator: Jean-chritophe FRICAIN, Md-PhD University Hospital, Bordeaux
Study Chair: Adélaïde DOUSSAU, MD University Hospital, Bordeaux
Study Director: Jean-christophe FRICAIN, MD-PhD University Hospital, Bordeaux
  More Information

No publications provided

Responsible Party: University Hospital, Bordeaux
ClinicalTrials.gov Identifier: NCT01167790     History of Changes
Other Study ID Numbers: CHUBX 2010/02
Study First Received: July 21, 2010
Last Updated: June 13, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by University Hospital, Bordeaux:
Precancerous lesions of the oral mucosa
Fluorescence visualization

ClinicalTrials.gov processed this record on July 24, 2014