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Screening for Cancers in the Oral CAvity (IDECAB)

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ClinicalTrials.gov Identifier: NCT01958762
Recruitment Status : Recruiting
First Posted : October 9, 2013
Last Update Posted : August 10, 2018
Sponsor:
Collaborators:
Picardy - Regional health agency (ARS)
Regional Council Picardie
Regional Observatory of Health and Social Issues in Picardie (OR2S)
Association for the screening of diseases in Somme (Adema 80)
Somme Cancer Registry
Information provided by (Responsible Party):
Centre Hospitalier Universitaire, Amiens

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 Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
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 : October 2013
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Oral Cancer

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



Primary Outcome Measures :
  1. Participation rate to the screening of the target patients. [ Time Frame: 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 :
  1. The participation rate of the physicians. [ Time Frame: 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.

  2. The participation rate of the tobacco venders. [ Time Frame: 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.



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Ages Eligible for Study:   30 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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:

-


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01958762


Contacts
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Contact: Bernard DEVAUCHELLE, MD, phD 033 3 22 66 83 25 devauchelle.bernard@chu-amiens.fr
Contact: Stéphanie DAKPE, MD 033 3 22 66 83 25 dakpe.stephanie@chu-amiens.fr

Locations
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France
Amiens University Hospital Recruiting
Amiens, Picardie, France, 80054
Contact: Stéphanie DAKPE, MD    0033 3 22 66 83 25    ddakpe.stephanie@chu-amiens.fr   
Amiens University Hospital Recruiting
Amiens, Picardie, France, 80054
Contact: Bernard DEVAUCHELLE, MD, phD    0033 3 22 66 83 25    devauchelle.bernard@chu-amiens.fr   
Sub-Investigator: Stéphanie DAKPE, MD         
Sponsors and Collaborators
Centre Hospitalier Universitaire, Amiens
Picardy - Regional health agency (ARS)
Regional Council Picardie
Regional Observatory of Health and Social Issues in Picardie (OR2S)
Association for the screening of diseases in Somme (Adema 80)
Somme Cancer Registry
Investigators
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Principal Investigator: Bernard DEVAUCHELLE, MD, phD Amiens University Hospital

Publications:
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Responsible Party: Centre Hospitalier Universitaire, Amiens
ClinicalTrials.gov Identifier: NCT01958762     History of Changes
Other Study ID Numbers: PI2013_843_0010
2013-A00606-39 ( Other Identifier: ID-RCB )
First Posted: October 9, 2013    Key Record Dates
Last Update Posted: August 10, 2018
Last Verified: August 2018

Keywords provided by Centre Hospitalier Universitaire, Amiens:
Screening
Cancer
Tobacco
General Practitioner
Precancerous Lesion
Dysplasia
Tobacco vendor

Additional relevant MeSH terms:
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Mouth Neoplasms
Head and Neck Neoplasms
Neoplasms by Site
Neoplasms
Mouth Diseases
Stomatognathic Diseases