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

Carcinoma, Squamous Cell Clinical Trial

— DEMO  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06094829
• Other study ID #: 69HCL22_0749
• Status: Not yet recruiting
• Start date: November 15, 2023
• Est. completion date: November 15, 2024

Study information

• Verified date: October 2023
• Source: Hospices Civils de Lyon
• Contact: Brigitte MD GROSGOGEAT
• Phone: 04 78 77 86 89
• Email: brigitte.grosgogeat[@]univ-lyon1.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: November 15, 2024
• Est. primary completion date: November 15, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Squamous Cell

Intervention

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

Locations

Country	Name	City	State
France	Cabinet Libéral Picquendar	Bougival
France	Cabinet Libéral Balayre	Chassieu
France	Cabinet Libéral Debeauvais	Châtillon-Coligny
France	Cabinet Libéral Finet	Fontaine-lès-Dijon
France	Cabinet Libéral Jaeggy	Haguenau
France	Cabinet Libéral Grammatica	Lyon
France	Centre de Consultations et de Traitements Dentaires HCL	Lyon
France	Unité de chirurgie et médecine orales (UCMO) - HCL - Hôpital Edouard Herriot- Pavillon R	Lyon
France	Cabinet Libéral Cougot	Meudon
France	Cabinet Libéral Calvo	Quint-Fonsegrives
France	Cabinet Libéral Glomet	Saumur
France	Cabinet Libéral Dutour	Theix
France	Cabinet Libéral Masri	Vandœuvre-lès-Nancy
France	Cabinet Libéral Bondil	Villefranche-sur-Saône
France	Cabinet Libéral Janisset-Masse	Villiers-sur-Marne

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevalence of non-synonymous OSCC driver mutations in the healthy mucosa of smokers	Difference in mean number of non-synonymous mutations found in OSCC driver genes between smokers and non-smokers.	12 months