Screening for Cancers in the Oral CAvity

Oral Cavity Cancer Clinical Trial

— IDECAB  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01958762
• Other study ID #: PI2013_843_0010
• Secondary ID: 2013-A00606-39
• Status: Recruiting
• Phase: N/A
• Start date: October 2013
• Est. completion date: December 2028

Study information

• Verified date: February 2023
• Source: Centre Hospitalier Universitaire, Amiens
• Contact: Bernard DEVAUCHELLE, MD, phD
• Phone: 033 3 22 66 83 25
• Email: devauchelle.bernard[@]chu-amiens.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 2028
• Est. primary completion date: December 2028
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 30 Years to 75 Years

Eligibility

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: -

Related Conditions & MeSH terms

• Mouth Neoplasms
• Oral Cavity Cancer

Intervention

Other:
• Invitation for oral cavity cancer screening

Locations

Country	Name	City	State
France	Amiens University Hospital	Amiens	Picardie
France	Amiens University Hospital	Amiens	Picardie

Sponsors (6)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire, Amiens	Association for the screening of diseases in Somme (Adema 80), Picardy - Regional health agency (ARS), Regional Council Picardie, Regional Observatory of Health and Social Issues in Picardie (OR2S), Somme Cancer Registry

Country where clinical trial is conducted

France, 

References & Publications (7)

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. — View 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. — View Citation

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

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

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	03 months after the start of the incentive period
Secondary	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.	15 days after the start of the incentive period