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

NCT ID: NCT06094829

Last Updated: 2024-06-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-11-23

Study Completion Date

2024-03-08

Brief Summary

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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.

Detailed Description

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Conditions

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Carcinoma, Squamous Cell

Study Design

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Observational Model Type

OTHER

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Smokers

Healthy subjects having smoked 100 cigarettes or more during their life.

Oral cytobrush

Intervention Type OTHER

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.

Oral cytobrush

Intervention Type OTHER

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

Interventions

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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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Hospices Civils de Lyon

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Cabinet Libéral Picquendar

Bougival, , France

Site Status

Cabinet Libéral Balayre

Chassieu, , France

Site Status

Cabinet Libéral Debeauvais

Châtillon-Coligny, , France

Site Status

Cabinet Libéral Finet

Fontaine-lès-Dijon, , France

Site Status

Cabinet Libéral Jaeggy

Haguenau, , France

Site Status

Unité de chirurgie et médecine orales (UCMO) - HCL - Hôpital Edouard Herriot- Pavillon R

Lyon, , France

Site Status

Centre de Consultations et de Traitements Dentaires HCL

Lyon, , France

Site Status

Cabinet Libéral Grammatica

Lyon, , France

Site Status

Cabinet Libéral Cougot

Meudon, , France

Site Status

Cabinet Libéral Calvo

Quint-Fonsegrives, , France

Site Status

Cabinet Libéral Glomet

Saumur, , France

Site Status

Cabinet Libéral Dutour

Theix, , France

Site Status

Cabinet Libéral Masri

Vandœuvre-lès-Nancy, , France

Site Status

Cabinet Libéral Bondil

Villefranche-sur-Saône, , France

Site Status

Cabinet Libéral Janisset-Masse

Villiers-sur-Marne, , France

Site Status

Countries

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France

Other Identifiers

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69HCL22_0749

Identifier Type: -

Identifier Source: org_study_id

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