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

Completed

• Conditions: Carcinoma, Squamous Cell
• Interventions: Other: Oral cytobrush

• Registration Number: NCT06094829
• Lead Sponsor: Hospices Civils de Lyon

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-10-16
• Study First Submitted QC: 2023-10-16
• Study First Posted: 2023-10-23
• Study Start: 2023-11-23
• Primary Completion: 2024-03-08
• Study Completion: 2024-03-08
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-25
• Last Update Posted: 2024-06-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Non-smokers	Oral cytobrush	Healthy subjects having smoked less than 100 cigarettes during their life.
Smokers	Oral cytobrush	Healthy subjects having smoked 100 cigarettes or more during their life.

Primary Outcome Measures

Name	Time	Method
Prevalence of non-synonymous OSCC driver mutations in the healthy mucosa of smokers	12 months	Difference in mean number of non-synonymous mutations found in OSCC driver genes between smokers and non-smokers.

Trial Locations

Locations (15)

Cabinet Libéral Picquendar; 🇫🇷 Bougival, France

Cabinet Libéral Glomet; 🇫🇷 Saumur, France

Cabinet Libéral Grammatica; 🇫🇷 Lyon, France

Cabinet Libéral Jaeggy; 🇫🇷 Haguenau, France

Cabinet Libéral Bondil; 🇫🇷 Villefranche-sur-Saône, France

Cabinet Libéral Debeauvais; 🇫🇷 Châtillon-Coligny, France

Centre de Consultations et de Traitements Dentaires HCL; 🇫🇷 Lyon, France

Cabinet Libéral Finet; 🇫🇷 Fontaine-lès-Dijon, France

Cabinet Libéral Calvo; 🇫🇷 Quint-Fonsegrives, France

Cabinet Libéral Masri; 🇫🇷 Vandœuvre-lès-Nancy, France

Cabinet Libéral Janisset-Masse; 🇫🇷 Villiers-sur-Marne, France

Cabinet Libéral Balayre; 🇫🇷 Chassieu, France

Cabinet Libéral Cougot; 🇫🇷 Meudon, France

Cabinet Libéral Dutour; 🇫🇷 Theix, France

Unité de chirurgie et médecine orales (UCMO) - HCL - Hôpital Edouard Herriot- Pavillon R; 🇫🇷 Lyon, France