Precancerous Lesions of the Oral MucosaFLUOKNCT01167790
Autofluorescence for the Screening of Precancerous and Malignant Lesions
A study testing buccal cavity examination in people with Precancerous Lesions of the Oral Mucosa, run by University Hospital, Bordeaux at 1 site in France.
Trial summary
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 ). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Precancerous Lesions of the Oral Mucosa
- What is being tested?
- buccal cavity examination
- Type of treatment
- Surgery or procedure
- How many people
- 180 participants
- Where
- 1 siteFrance
- Study dates
- Jul 2010to Mar 2012
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients hospitalized for alcoholic weaning
- consumption activates of tobacco or stop for less than one year
- consent form signed
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Interest of Oral Tissue Autofluorescence for the Screening of Precancerous Lesions and Cancer in Population With Tobacco and Alcohol Abuse.
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.
Read the 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.
- Conditions
- Precancerous Lesions of the Oral Mucosa
- Being tested
- buccal cavity examination
- Keywords
- Precancerous lesions of the oral mucosa, Fluorescence visualization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
buccal cavity examinationProcedure or surgery
autofluorescence examination
What is being measured
The primary outcome is the main question the study is designed to answer.
reliability
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)
Measured: one day
Secondary outcomes (3)
Prevalence
Prevalence of potentially malignant lesions, dysplasia and cancer patient of the oral cavity in conditions of screening in an alcoolo-smoking population.
Measured: one day
Validity
anatomopathologic diagnosis wil be compared to examination in both techniques of examination
Measured: one day
safety
adverse events of the procedure (biopsy)
Measured: one day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2010 (estimated)
- Study startJul 2010
- Primary completionMar 2012
- Study completionMar 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Precancerous Lesions of the Oral MucosaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean-chritophe FRICAIN, Md-PhD, Principal investigator, University Hospital, BordeauxAdélaïde DOUSSAU, MD, Study chair, University Hospital, BordeauxJean-christophe FRICAIN, MD-PhD, Study director, University Hospital, Bordeaux
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01167790
- Sponsor's protocol ID
- CHUBX 2010/02
- Other IDs
- 2010-A00262-37
- Acronym
- FLUOK
- Status last verified
- Jun 2012
- First submitted
- 21 Jul 2010
- Last updated
- 20 May 2026
- Results posted
- No
- Data monitoring committee
- No