Clinical trial NCT01958762: Screening for Cancers in the Oral CAvity
Official title: Screening for Cancers in the Oral CAvity Targeting Tobacco Users in Somme, France
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Oral Cavity Cancer
Keywords: Screening
Cancer
Tobacco
General Practitioner
Precancerous Lesion
Dysplasia
Tobacco vendor
Lead sponsor: Centre Hospitalier Universitaire, Amiens
Sponsor class: OTHER
Collaborators: name: Picardy - Regional health agency (ARS)
name: Regional Council Picardie
name: Regional Observatory of Health and Social Issues in Picardie (OR2S)
name: Association for the screening of diseases in Somme (Adema 80)
name: Somme Cancer Registry
First posted: 2013-10-09
Enrollment: 100
Sex: ALL
Minimum age (years): 30
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: In the Somme region of France, cancer registry data showed an increasing incidence of oral cancer. The Incidence Rates in Somme as compared to the national rates for Lip, Oral Cavity and Pharynx Cancer were in 2010: 31,4/100 000 Standard population versus 18,2 /100 000 for male and 8,2/100 000 versus 5,5/100 000 for female, disaster area where action to improve early detection for smokers will be assessed. This target population consults late (as 70% of oral cavity cancers are diagnosed at a late stage (T3 or T4). This project is an innovative incentive strategy for screening among general practitioners based on unusual information vectors (tobacconist, local media).

The main objective of this study is a screening of oral cavity cancers in tobacco users aged 30-75 years in the Somme region of France.

Detailed description: Methodology:

* Education and alerting physicians to the early detection of cancers of oral cavity and coordination of networks involved for 1 year.
* Incentive period for the screening by the tobacconist who distributes with every package of cigarettes bought a flyer of invitation to the screening.
* Carrying out screening examinations by general practitioners with completion of the customized examination forms, orientation towards a specialist, data collection and evaluation.

Eligibility criteria: Inclusion Criteria:

* Any smoker who buys a pack of cigarettes over a period of two weeks in a tobacco shop located on the territory of the Somme
* lives in somme departement

Exclusion Criteria:

-

Primary outcomes:
measure: Participation rate to the screening of the target patients.
timeFrame: 03 months after the start of the incentive period
Secondary outcomes:
measure: The participation rate of the physicians.
timeFrame: 03 months after the start of the incentive period
measure: The participation rate of the tobacco venders.
timeFrame: 15 days after the start of the incentive period
Other outcomes:
Locations:
city: Amiens
country: France
facility: Amiens University Hospital
state: Picardie
city: Amiens
country: France
facility: Amiens University Hospital
state: Picardie
Study officials:
affiliation: Amiens University Hospital
name: Bernard DEVAUCHELLE, MD, phD
role: PRINCIPAL_INVESTIGATOR
References:
citation: http://www.cepidc.vesinet.inserm.fr/
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