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

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.

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Key information

Conditions

Carcinoma, Squamous Cell Carcinoma Head and Neck Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Neoplasms, Squamous Cell Squamous Cell Carcinoma of Head and Neck

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Cabinet Libéral Picquendar, Bougival, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Oral cytobrush

Other

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

Primary outcomes

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.

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Acronym: DEMO

Important dates

Study start: 2023
Primary completion: 2024
Study completion: 2024
First posted: Oct 23, 2023
Registry last updated: May 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed