NCT01958762

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
31mo left

Started Oct 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress83%
Oct 2013Dec 2028

Study Start

First participant enrolled

October 1, 2013

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

October 7, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 9, 2013

Completed
15.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2028

Last Updated

February 8, 2023

Status Verified

February 1, 2023

Enrollment Period

15.2 years

First QC Date

October 7, 2013

Last Update Submit

February 7, 2023

Conditions

Oral Cavity Cancer

Keywords

ScreeningCancerTobaccoGeneral PractitionerPrecancerous LesionDysplasiaTobacco vendor

Outcome Measures

Primary Outcomes (1)

  • 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.

    03 months after the start of the incentive period

Secondary Outcomes (2)

  • The participation rate of the physicians.

    03 months after the start of the incentive period

  • The participation rate of the tobacco venders.

    15 days after the start of the incentive period

Study Arms (1)

Screening for cancers in the oral cavity

OTHER
Other: Invitation for oral cavity cancer screening

Interventions

Invitation for oral cavity cancer screeningOTHER
Screening for cancers in the oral cavity

Eligibility Criteria

Age30 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Amiens University Hospital

Amiens, Picardie, 80054, France

RECRUITING

Amiens University Hospital

Amiens, Picardie, 80054, France

RECRUITING

Related Publications (7)

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

    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.

    PMID: 22006132BACKGROUND

  • 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.

    PMID: 19377716BACKGROUND

  • 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.

    PMID: 17996486BACKGROUND

  • 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.

    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

    BACKGROUND

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

    BACKGROUND

MeSH Terms

Conditions

Mouth NeoplasmsNeoplasms

Condition Hierarchy (Ancestors)

Head and Neck NeoplasmsNeoplasms by SiteMouth DiseasesStomatognathic Diseases

Study Officials

  • Bernard DEVAUCHELLE, MD, phD

    Amiens University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Bernard DEVAUCHELLE, MD, phD

CONTACT

033 3 22 66 83 25devauchelle.bernard@chu-amiens.fr

Stéphanie DAKPE, MD

CONTACT

033 3 22 66 83 25dakpe.stephanie@chu-amiens.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 7, 2013

First Posted

October 9, 2013

Study Start

October 1, 2013

Primary Completion (Estimated)

December 1, 2028

Study Completion (Estimated)

December 1, 2028

Last Updated

February 8, 2023

Record last verified: 2023-02

Locations

FR(2)