IDECAB: Screening for Cancers in the Oral CAvity

Sponsor

Centre Hospitalier Universitaire, Amiens (Other)

Overall Status

Recruiting

CT.gov ID

NCT01958762

Collaborator

Picardy - Regional health agency (ARS) (Other), Regional Council Picardie (Other), Regional Observatory of Health and Social Issues in Picardie (OR2S) (Other), Association for the screening of diseases in Somme (Adema 80) (Other), Somme Cancer Registry (Other)

100

Enrollment

Locations

Arm

182

Duration (Months)

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Oral Cavity Cancer	Other: Invitation for oral cavity cancer screening	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

Screening for Cancers in the Oral CAvity Targeting Tobacco Users in Somme, France

Study Start Date :

Oct 1, 2013

Anticipated Primary Completion Date :

Dec 1, 2028

Anticipated Study Completion Date :

Dec 1, 2028

Arms and Interventions

Arm	Intervention/Treatment
Other: Screening for cancers in the oral cavity	Other: Invitation for oral cavity cancer screening

Arm

Intervention/Treatment

Other: Screening for cancers in the oral cavity

Other: Invitation for oral cavity cancer screening

Outcome Measures

Primary Outcome Measures

Participation rate to the screening of the target patients. [03 months after the start of the incentive period]
Numbers of people who benefit from a screening exam by a physician of the Somme region in comparison, with the target population of the Somme region. This rate will be also calculated according the different of age and sex.

Secondary Outcome Measures

The participation rate of the physicians. [03 months after the start of the incentive period]
Number of physicians who send back at least one clinical form compared to the numbers of physician of the Somme.
The participation rate of the tobacco venders. [15 days after the start of the incentive period]
The number of tobacco venders who gave at least 01 " Flyer " in comparison to the numbers of tobacco venders of the Somme.