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Recruiting NCT01958762

Screening for Cancers in the Oral CAvity

No phase Interventional Oral Cavity Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Invitation for oral cavity cancer screening.
Who it may be relevant to
Registry conditions: Oral Cavity Cancer. Basic parameters: 30 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Other Invitation for oral cavity cancer screening

Primary outcome measures

  • Participation rate to the screening of the target patients. [Time frame: 03 months after the start of the incentive period]
Secondary outcome measures (2)
  • The participation rate of the physicians. [Time frame: 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]

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

\-

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Prevention

Study locations

France · 2 centers
  • Amiens University Hospital — Amiens
  • Amiens University Hospital — Amiens

Publications

  • http://www.cepidc.vesinet.inserm.fr/
  • 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 22006132
  • 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 19377716
  • 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 17996486
  • 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.
  • 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
  • Reyt E, Righini C. Les cancers du plancher buccal. La chirurgie mini-invasive. Société française de carcinologie cervico-faciale.EDK

Identifiers

NCT: NCT01958762 · PI2013_843_0010 · 2013-A00606-39

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗