Oral Cavity CancerIDECABNCT01958762
Screening for Cancers in the Oral CAvity
A study testing Invitation for oral cavity cancer screening in people with Oral Cavity Cancer, run by Centre Hospitalier Universitaire, Amiens at 2 sites in France.
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… Read more about this study
- Who is it for?
- Ages 30 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Oral Cavity Cancer
- What is being tested?
- Invitation for oral cavity cancer screening
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 2 sitesFrance
- Study dates
- Oct 2013to Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- -
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France2 sites, 2 recruiting
- Recruiting
Amiens University Hospital
Amiens, Picardie, 80054
Stéphanie DAKPE, MD, 0033 3 22 66 83 25, ddakpe.stephanie@chu-amiens.fr
- Recruiting
Amiens University Hospital
Amiens, Picardie, 80054
Bernard DEVAUCHELLE, MD, phD, 0033 3 22 66 83 25, devauchelle.bernard@chu-amiens.fr
Stéphanie DAKPE, MD
About this study
Official title: Screening for Cancers in the Oral CAvity Targeting Tobacco Users in Somme, France
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.
Read the 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.
- Conditions
- Oral Cavity Cancer
- Being tested
- Invitation for oral cavity cancer screening
- Keywords
- Screening, Cancer, Tobacco, General Practitioner, Precancerous Lesion, Dysplasia, Tobacco vendor
- Medical subject headings
- Mouth Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Invitation for oral cavity cancer screeningOther
| Study group | Role | What they receive |
|---|---|---|
| Screening for cancers in the oral cavity | Other | Not described Receives: Other: Invitation for oral cavity cancer screening |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 03 months after the start of the incentive period
Secondary outcomes (2)
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.
Measured: 03 months after the start of the incentive period
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.
Measured: 15 days after the start of the incentive period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2013 (estimated)
- Study startOct 2013
- Primary completionDec 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Oral Cavity CancerStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire, AmiensThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire, Amiens
- Sponsor type
- University, hospital or other
- 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
- Responsible party
- Sponsor
- Investigators
- Bernard DEVAUCHELLE, MD, phD, Principal investigator, Amiens University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01958762
- Sponsor's protocol ID
- PI2013_843_0010
- Other IDs
- 2013-A00606-39
- Acronym
- IDECAB
- Status last verified
- Feb 2023
- First submitted
- 7 Oct 2013
- Last updated
- 8 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 22006132Subramanian 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.
PubMed 19377716Epstein 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.
PubMed 17996486Hubert 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
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Screening for Cancers in the Oral CAvity Targeting Tobacco Users in Somme, France
- ClinicalTrials.gov ID
- NCT01958762
- Acronym / sponsor ID
- IDECAB / PI2013_843_0010
- Conditions
- Oral Cavity Cancer
- Keywords
- Screening, Cancer, Tobacco, General Practitioner, Precancerous Lesion, Dysplasia, Tobacco vendor
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire, AmiensUniversity, hospital or other
- 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
- Study start
- Oct 2013
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 9 Oct 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Screening for cancers in the oral cavity | Other | Other: Invitation for oral cavity cancer screening |
Who may qualify
- Ages
- 30 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Invitation for oral cavity cancer screening | Other | Screening for cancers in the oral cavity |
Primary outcome
Participation rate to the screening of the target patients.
Time frame: 03 months after the start of the incentive period
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.
2 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2023.
- Backgroundhttp://www.cepidc.vesinet.inserm.fr/
- Background: PubMed 22006132Bailey 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.
- Background: PubMed 19377716Subramanian 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.
- Background: PubMed 17996486Epstein 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.
- BackgroundHubert 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.
- BackgroundRéseau 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
- BackgroundReyt E, Righini C. Les cancers du plancher buccal. La chirurgie mini-invasive. Société française de carcinologie cervico-faciale.EDK
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Bernard DEVAUCHELLE, MD, phD principal investigator
Amiens University Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Invitation for oral cavity cancer screening in people with Oral Cavity Cancer, run by Centre Hospitalier Universitaire, Amiens at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Bernard DEVAUCHELLE, MD, phD (033 3 22 66 83 25, devauchelle.bernard@chu-amiens.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participation rate to the screening of the target patients. (time frame: 03 months after the start of the incentive period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01958762, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2023.