Clinical trial NCT06094829: Tobacco and Alcohol Influence on Oncogenic Drivers and Somatic Evolution in the Oral Mucosa
Official title: Tobacco and Alcohol Influence on Oncogenic Drivers and Somatic Evolution in the Oral Mucosa
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Carcinoma, Squamous Cell
Keywords: Oral cytobrush
Healthy oral mucosa
Oral squamous cell carcinoma
Tobacco and alcohol
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2023-10-23
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects coming to odontology practices for routine visits

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.


Eligibility criteria: 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

Primary outcomes:
measure: Prevalence of non-synonymous OSCC driver mutations in the healthy mucosa of smokers
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Bougival
country: France
facility: Cabinet Libéral Picquendar
city: Chassieu
country: France
facility: Cabinet Libéral Balayre
city: Châtillon-Coligny
country: France
facility: Cabinet Libéral Debeauvais
city: Fontaine-lès-Dijon
country: France
facility: Cabinet Libéral Finet
city: Haguenau
country: France
facility: Cabinet Libéral Jaeggy
city: Lyon
country: France
facility: Unité de chirurgie et médecine orales (UCMO) - HCL - Hôpital Edouard Herriot- Pavillon R
city: Lyon
country: France
facility: Centre de Consultations et de Traitements Dentaires HCL
city: Lyon
country: France
facility: Cabinet Libéral Grammatica
city: Meudon
country: France
facility: Cabinet Libéral Cougot
city: Quint-Fonsegrives
country: France
facility: Cabinet Libéral Calvo
city: Saumur
country: France
facility: Cabinet Libéral Glomet
city: Theix
country: France
facility: Cabinet Libéral Dutour
city: Vandœuvre-lès-Nancy
country: France
facility: Cabinet Libéral Masri
city: Villefranche-sur-Saône
country: France
facility: Cabinet Libéral Bondil
city: Villiers-sur-Marne
country: France
facility: Cabinet Libéral Janisset-Masse
Study officials:
References: