Carcinoma, Squamous CellDEMONCT06094829
Tobacco and Alcohol Influence on Oncogenic Drivers and Somatic Evolution in the Oral Mucosa
An observational study of Carcinoma, Squamous Cell, run by Hospices Civils de Lyon at 15 sites in France.
Trial summary
Head and neck cancers represent more than 500,000 cases per year worldwide, and often involve post-treatment relapse. The oral cavity is the most frequent site, but early disease stages are still insufficiently characterised and poorly detected. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Carcinoma, Squamous Cell
- What is being tested?
- Oral cytobrush
- Type of treatment
- Pill or oral medicine
- How many people
- 100 participants
- Where
- 15 sitesFrance
- Study dates
- 23 Nov 2023to 8 Mar 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Subjects coming to odontology practices for routine visits
Who may be able to join
- Man or woman aged 18 or more.
- Subject coming to odontology practice for routine visit.
- Subject having accepted to participate to the research by oral non-opposition
- Subject having given additional written consent for genetic studies.
- Smoking group criterion: subjects having smoked 100+ cigarettes/joints during their life.
Who cannot join
- Personal history of cancer, whichever the type.
- Treatment with anticoagulants or platelet aggregation inhibitors.
- Bilateral lesions of the inner cheek preventing painless biological sample collection.
- Subject under under guardians or curators
- Pregnancy or breastfeeding
- Cannabis usage
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
France15 sites
Cabinet Libéral Picquendar
Bougival, 78380
Cabinet Libéral Balayre
Chassieu, 69680
Cabinet Libéral Debeauvais
Châtillon-Coligny, 45230
Cabinet Libéral Finet
Fontaine-lès-Dijon, 21121
Cabinet Libéral Jaeggy
Haguenau, 67500
Unité de chirurgie et médecine orales (UCMO) - HCL - Hôpital Edouard Herriot- Pavillon R
Lyon, 69003
Centre de Consultations et de Traitements Dentaires HCL
Lyon, 69007
Cabinet Libéral Grammatica
Lyon, 69008
Cabinet Libéral Cougot
Meudon, 92190
Cabinet Libéral Calvo
Quint-Fonsegrives, 31130
Cabinet Libéral Glomet
Saumur, 49400
Cabinet Libéral Dutour
Theix, 63122
Cabinet Libéral Masri
Vandœuvre-lès-Nancy, 54500
Cabinet Libéral Bondil
Villefranche-sur-Saône, 69400
Cabinet Libéral Janisset-Masse
Villiers-sur-Marne, 95350
About this study
Head and neck cancers represent more than 500,000 cases per year worldwide, and often involve post-treatment relapse. The oral cavity is the most frequent site, but early disease stages are still insufficiently characterised and poorly detected. The study's aim is to better understand the oral mucosa somatic evolution, and how it can give rise to oral squamous cell carcinoma (OSCC).
This is a multi-centric, descriptive, non-interventional cohort in healthy adult subjects. The aim of the study is to detect the presence of OSCC driver gene mutations in healthy subjects' oral mucosa, quantify whether they provide cells with a selective advantage, and study the impact of tobacco and alcohol consumption on the mutational load. This study will not allow to identify potential malignant cells, and will be usable for diagnostic purposes.
- Conditions
- Carcinoma, Squamous Cell
- Being tested
- Oral cytobrush
- Keywords
- Oral cytobrush, Healthy oral mucosa, Oral squamous cell carcinoma, Tobacco and alcohol
- Medical subject headings
- Carcinoma, Squamous Cell, Squamous Cell Carcinoma of Head and Neck
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral cytobrushOther
Oral epithelial cells will be collected during routine odontology appointments, upon documented non-opposition, via minimally invasive cytobrush sampling of the inner cheek
| Study group | Role | What they receive |
|---|---|---|
| Smokers | Healthy subjects having smoked 100 cigarettes or more during their life. Receives: Other: Oral cytobrush | |
| Non-smokers | Healthy subjects having smoked less than 100 cigarettes during their life. Receives: Other: Oral cytobrush |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of non-synonymous OSCC driver mutations in the healthy mucosa of smokers
Difference in mean number of non-synonymous mutations found in OSCC driver genes between smokers and non-smokers.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2023
- Study start23 Nov 2023
- Primary completion8 Mar 2024
- Study completion8 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carcinoma, Squamous CellStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe 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
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Brigitte GROSGOGEAT, MD, Principal investigator, Centre de Consultations et de Traitements Dentaires HCL, Lyon, 69007
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06094829
- Sponsor's protocol ID
- 69HCL22_0749
- Acronym
- DEMO
- Status last verified
- Jun 2024
- First submitted
- 16 Oct 2023
- Last updated
- 5 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tobacco and Alcohol Influence on Oncogenic Drivers and Somatic Evolution in the Oral Mucosa
- ClinicalTrials.gov ID
- NCT06094829
- Acronym / sponsor ID
- DEMO / 69HCL22_0749
- Conditions
- Carcinoma, Squamous Cell
- Keywords
- Oral cytobrush, Healthy oral mucosa, Oral squamous cell carcinoma, Tobacco and alcohol
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 23 Nov 2023 (actual)
- Primary completion
- 8 Mar 2024 (actual)
- Study completion
- 8 Mar 2024 (actual)
- First posted
- 23 Oct 2023 (actual)
- 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.
Head and neck cancers represent more than 500,000 cases per year worldwide, and often involve post-treatment relapse. The oral cavity is the most frequent site, but early disease stages are still insufficiently characterised and poorly detected. The study's aim is to better understand the oral mucosa somatic evolution, and how it can give rise to oral squamous cell carcinoma (OSCC).
This is a multi-centric, descriptive, non-interventional cohort in healthy adult subjects. The aim of the study is to detect the presence of OSCC driver gene mutations in healthy subjects' oral mucosa, quantify whether they provide cells with a selective advantage, and study the impact of tobacco and alcohol consumption on the mutational load. This study will not allow to identify potential malignant cells, and will be usable for diagnostic purposes.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Smokers | – | Other: Oral cytobrushHealthy subjects having smoked 100 cigarettes or more during their life. |
| Non-smokers | – | Other: Oral cytobrushHealthy subjects having smoked less than 100 cigarettes during their life. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects coming to odontology practices for routine visits
Key inclusion criteria (5 listed)
- Man or woman aged 18 or more.
- Subject coming to odontology practice for routine visit.
- Subject having accepted to participate to the research by oral non-opposition
- Subject having given additional written consent for genetic studies.
- Smoking group criterion: subjects having smoked 100+ cigarettes/joints during their life.
Key exclusion criteria (6 listed)
- Personal history of cancer, whichever the type.
- Treatment with anticoagulants or platelet aggregation inhibitors.
- Bilateral lesions of the inner cheek preventing painless biological sample collection.
- Subject under under guardians or curators
- Pregnancy or breastfeeding
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 |
|---|---|---|
| Oral cytobrushOral epithelial cells will be collected during routine odontology appointments, upon documented non-opposition, via minimally invasive cytobrush sampling of the inner cheek | Other | Non-smokers, Smokers |
Primary outcome
Prevalence of non-synonymous OSCC driver mutations in the healthy mucosa of smokers
Time frame: 12 months
Difference in mean number of non-synonymous mutations found in OSCC driver genes between smokers and non-smokers.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2026.
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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. This study is not recruiting at the moment.
Brigitte GROSGOGEAT, MD principal investigator
Centre de Consultations et de Traitements Dentaires HCL, Lyon, 69007
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Carcinoma, Squamous Cell, run by Hospices Civils de Lyon at 15 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 5 inclusion and 6 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: finished, as of the sponsor's last update on 5 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of non-synonymous OSCC driver mutations in the healthy mucosa of smokers (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 May 2026.