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Tobacco and Alcohol Influence on Oncogenic Drivers and Somatic Evolution in the Oral Mucosa

Tobacco and Alcohol Influence on Oncogenic Drivers and Somatic Evolution in the Oral Mucosa

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06094829
Acronym
DEMO
Enrollment
100
Registered
2023-10-23
Start date
2023-11-23
Completion date
2024-03-08
Last updated
2026-05-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Carcinoma, Squamous Cell

Keywords

Oral cytobrush, Healthy oral mucosa, Oral squamous cell carcinoma, Tobacco and alcohol

Brief 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. 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.

Interventions

OTHEROral cytobrush

Oral epithelial cells will be collected during routine odontology appointments, upon documented non-opposition, via minimally invasive cytobrush sampling of the inner cheek

Sponsors

Hospices Civils de Lyon
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* 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.

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
Prevalence of non-synonymous OSCC driver mutations in the healthy mucosa of smokers12 monthsDifference in mean number of non-synonymous mutations found in OSCC driver genes between smokers and non-smokers.

Countries

France

Contacts

PRINCIPAL_INVESTIGATORBrigitte GROSGOGEAT, MD

Centre de Consultations et de Traitements Dentaires HCL, Lyon, 69007

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 6, 2026