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

May 4, 2026 updated by: Hospices Civils de Lyon

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Bougival, France, 78380
        • Cabinet Libéral Picquendar
      • Chassieu, France, 69680
        • Cabinet Libéral Balayre
      • Châtillon-Coligny, France, 45230
        • Cabinet Libéral Debeauvais
      • Fontaine-lès-Dijon, France, 21121
        • Cabinet Libéral Finet
      • Haguenau, France, 67500
        • Cabinet Libéral Jaeggy
      • Lyon, France, 69003
        • Unité de chirurgie et médecine orales (UCMO) - HCL - Hôpital Edouard Herriot- Pavillon R
      • Lyon, France, 69007
        • Centre de Consultations et de Traitements Dentaires HCL
      • Lyon, France, 69008
        • Cabinet Libéral Grammatica
      • Meudon, France, 92190
        • Cabinet Libéral Cougot
      • Quint-Fonsegrives, France, 31130
        • Cabinet Libéral Calvo
      • Saumur, France, 49400
        • Cabinet Libéral Glomet
      • Theix, France, 63122
        • Cabinet Libéral Dutour
      • Vandœuvre-lès-Nancy, France, 54500
        • Cabinet Libéral Masri
      • Villefranche-sur-Saône, France, 69400
        • Cabinet Libéral Bondil
      • Villiers-sur-Marne, France, 95350
        • Cabinet Libéral Janisset-Masse

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Subjects coming to odontology practices for routine visits

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Smokers
Healthy subjects having smoked 100 cigarettes or more during their life.
Other: Oral cytobrush
Oral epithelial cells will be collected during routine odontology appointments, upon documented non-opposition, via minimally invasive cytobrush sampling of the inner cheek
Non-smokers
Healthy subjects having smoked less than 100 cigarettes during their life.
Other: Oral cytobrush
Oral epithelial cells will be collected during routine odontology appointments, upon documented non-opposition, via minimally invasive cytobrush sampling of the inner cheek

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospices Civils de Lyon

Investigators

  • Principal Investigator: Brigitte GROSGOGEAT, MD, Centre de Consultations et de Traitements Dentaires HCL, Lyon, 69007

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 23, 2023

Primary Completion (Actual)

March 8, 2024

Study Completion (Actual)

March 8, 2024

Study Registration Dates

First Submitted

October 16, 2023

First Submitted That Met QC Criteria

October 16, 2023

First Posted (Actual)

October 23, 2023

Study Record Updates

Last Update Posted (Actual)

May 5, 2026

Last Update Submitted That Met QC Criteria

May 4, 2026

Last Verified

June 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 69HCL22_0749

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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