Screening for Cancers in the Oral CAvity

NCT ID: NCT01958762

Last Updated: 2023-02-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-10-31

Study Completion Date

2028-12-31

Brief Summary

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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

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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.

Conditions

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Oral Cavity Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Screening for cancers in the oral cavity

Group Type OTHER

Invitation for oral cavity cancer screening

Intervention Type OTHER

Interventions

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Invitation for oral cavity cancer screening

Intervention Type OTHER

Eligibility Criteria

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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

\-
Minimum Eligible Age

30 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Picardy - Regional health agency (ARS)

UNKNOWN

Sponsor Role collaborator

Regional Council Picardie

UNKNOWN

Sponsor Role collaborator

Regional Observatory of Health and Social Issues in Picardie (OR2S)

UNKNOWN

Sponsor Role collaborator

Association for the screening of diseases in Somme (Adema 80)

UNKNOWN

Sponsor Role collaborator

Somme Cancer Registry

UNKNOWN

Sponsor Role collaborator

Centre Hospitalier Universitaire, Amiens

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bernard DEVAUCHELLE, MD, phD

Role: PRINCIPAL_INVESTIGATOR

Amiens University Hospital

Locations

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Amiens University Hospital

Amiens, Picardie, France

Site Status RECRUITING

Amiens University Hospital

Amiens, Picardie, France

Site Status RECRUITING

Countries

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France

Central Contacts

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Bernard DEVAUCHELLE, MD, phD

Role: CONTACT

033 3 22 66 83 25

Stéphanie DAKPE, MD

Role: CONTACT

033 3 22 66 83 25

Facility Contacts

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Stéphanie DAKPE, MD

Role: primary

0033 3 22 66 83 25

Bernard DEVAUCHELLE, MD, phD

Role: primary

0033 3 22 66 83 25

References

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http://www.cepidc.vesinet.inserm.fr/

Reference Type BACKGROUND

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.

Reference Type BACKGROUND
PMID: 22006132 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19377716 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17996486 (View on PubMed)

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.

Reference Type BACKGROUND

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

Reference Type BACKGROUND

Reyt E, Righini C. Les cancers du plancher buccal. La chirurgie mini-invasive. Société française de carcinologie cervico-faciale.EDK

Reference Type BACKGROUND

Other Identifiers

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2013-A00606-39

Identifier Type: OTHER

Identifier Source: secondary_id

PI2013_843_0010

Identifier Type: -

Identifier Source: org_study_id

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