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Screening for Cancers in the Oral CAvity (IDECAB)

Primary Purpose

Oral Cavity Cancer

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Invitation for oral cavity cancer screening
Sponsored by
Centre Hospitalier Universitaire, Amiens
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Oral Cavity Cancer focused on measuring Screening, Cancer, Tobacco, General Practitioner, Precancerous Lesion, Dysplasia, Tobacco vendor

Eligibility Criteria

30 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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:

-

Sites / Locations

  • Amiens University HospitalRecruiting
  • Amiens University HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Screening for cancers in the oral cavity

Arm Description

Outcomes

Primary Outcome Measures

Participation rate to the screening of the target patients.
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.
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.
The number of tobacco venders who gave at least 01 " Flyer " in comparison to the numbers of tobacco venders of the Somme.

Full Information

First Posted
October 7, 2013
Last Updated
February 7, 2023
Sponsor
Centre Hospitalier Universitaire, Amiens
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
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1. Study Identification

Unique Protocol Identification Number
NCT01958762
Brief Title
Screening for Cancers in the Oral CAvity
Acronym
IDECAB
Official Title
Screening for Cancers in the Oral CAvity Targeting Tobacco Users in Somme, France
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 2013 (undefined)
Primary Completion Date
December 2028 (Anticipated)
Study Completion Date
December 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire, Amiens
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

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Oral Cavity Cancer
Keywords
Screening, Cancer, Tobacco, General Practitioner, Precancerous Lesion, Dysplasia, Tobacco vendor

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Screening for cancers in the oral cavity
Arm Type
Other
Intervention Type
Other
Intervention Name(s)
Invitation for oral cavity cancer screening
Primary Outcome Measure Information:
Title
Participation rate to the screening of the target patients.
Description
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.
Time Frame
03 months after the start of the incentive period
Secondary Outcome Measure Information:
Title
The participation rate of the physicians.
Description
Number of physicians who send back at least one clinical form compared to the numbers of physician of the Somme.
Time Frame
03 months after the start of the incentive period
Title
The participation rate of the tobacco venders.
Description
The number of tobacco venders who gave at least 01 " Flyer " in comparison to the numbers of tobacco venders of the Somme.
Time Frame
15 days after the start of the incentive period

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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: -
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Bernard DEVAUCHELLE, MD, phD
Phone
033 3 22 66 83 25
Email
devauchelle.bernard@chu-amiens.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Stéphanie DAKPE, MD
Phone
033 3 22 66 83 25
Email
dakpe.stephanie@chu-amiens.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bernard DEVAUCHELLE, MD, phD
Organizational Affiliation
Amiens University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Amiens University Hospital
City
Amiens
State/Province
Picardie
ZIP/Postal Code
80054
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stéphanie DAKPE, MD
Phone
0033 3 22 66 83 25
Email
ddakpe.stephanie@chu-amiens.fr
Facility Name
Amiens University Hospital
City
Amiens
State/Province
Picardie
ZIP/Postal Code
80054
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bernard DEVAUCHELLE, MD, phD
Phone
0033 3 22 66 83 25
Email
devauchelle.bernard@chu-amiens.fr
First Name & Middle Initial & Last Name & Degree
Stéphanie DAKPE, MD

12. IPD Sharing Statement

Citations:
Citation
http://www.cepidc.vesinet.inserm.fr/
Results Reference
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PubMed Identifier
22006132
Citation
Bailey EE, Marghoob AA, Orengo IF, Testa MA, White VR, Geller AC. Skin cancer knowledge, attitudes, and behaviors in the salon: a survey of working hair professionals in Houston, Texas. Arch Dermatol. 2011 Oct;147(10):1159-65. doi: 10.1001/archdermatol.2011.184.
Results Reference
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PubMed Identifier
19377716
Citation
Subramanian S, Sankaranarayanan R, Bapat B, Somanathan T, Thomas G, Mathew B, Vinoda J, Ramadas K. Cost-effectiveness of oral cancer screening: results from a cluster randomized controlled trial in India. Bull World Health Organ. 2009 Mar;87(3):200-6. doi: 10.2471/blt.08.053231.
Results Reference
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PubMed Identifier
17996486
Citation
Epstein JB, Silverman S Jr, Epstein JD, Lonky SA, Bride MA. Analysis of oral lesion biopsies identified and evaluated by visual examination, chemiluminescence and toluidine blue. Oral Oncol. 2008 Jun;44(6):538-44. doi: 10.1016/j.oraloncology.2007.08.011. Epub 2007 Nov 8. Erratum In: Oral Oncol. 2008 Jun;44(6):615.
Results Reference
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Citation
Hubert A, Lapôtre B, Raverdy N, Ganry O. Incidence et mortalité 2002-2004 Evolution de 1982 à 2004. Registre du Cancer de la Somme. Juin 2009. 138 p.
Results Reference
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Citation
Réseau Francim, service de biostatistique des hospices civils de Lyon. Survie des patients atteints de Cancer en France : étude des registres du réseau Francim, Paris 2007, springer, 406
Results Reference
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Citation
Reyt E, Righini C. Les cancers du plancher buccal. La chirurgie mini-invasive. Société française de carcinologie cervico-faciale.EDK
Results Reference
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Screening for Cancers in the Oral CAvity

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