Screening for Cancers in the Oral CAvity (IDECAB)

February 7, 2023 updated by: Centre Hospitalier Universitaire, Amiens

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
    • Picardie
      • Amiens, Picardie, France, 80054
        • Recruiting
        • Amiens University Hospital
        • Sub-Investigator:
          • Stéphanie DAKPE, MD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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:

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
03 months after the start of the incentive period

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
03 months after the start of the incentive period
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.
15 days after the start of the incentive period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire, Amiens

Collaborators

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

Investigators

  • Principal Investigator: Bernard DEVAUCHELLE, MD, phD, Amiens University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2013

Primary Completion (ANTICIPATED)

December 1, 2028

Study Completion (ANTICIPATED)

December 1, 2028

Study Registration Dates

First Submitted

October 7, 2013

First Submitted That Met QC Criteria

October 7, 2013

First Posted (ESTIMATE)

October 9, 2013

Study Record Updates

Last Update Posted (ACTUAL)

February 8, 2023

Last Update Submitted That Met QC Criteria

February 7, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PI2013_843_0010
  • 2013-A00606-39 (OTHER: ID-RCB)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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